linjc16/ctgov huggingface dataset:
Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and platelet volume indices levels as biomarkers in ankylosing spondylitis.

Official Title
-----------------
Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spodylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Diagnostic Test: CBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS AGE MORE THAN 18 YEARS Exclusion Criteria: PATIENT WITH CARDIAC ,CEREBROVASCULAR AND HEMATOLOGIC DIEASE PTIENT WITH HYPERTENSION ,DIABETES ,METABOLIS SYNDROMES AND OTHER AUTOIMMUNE RHEUMATIC DISEASES.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| cases group<br> | Diagnostic Test: CBC<br>* Platelet and red blood cell volume indices<br>|
| control group<br> | Diagnostic Test: CBC<br>* Platelet and red blood cell volume indices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet | platelet cell volume indices | 6 months | 
| Red blood cell | red blood cell volume indices | 6 months |
Erector Spinae Regional Anesthesia for Pain Control

Study Overview
=================
Brief Summary
-----------------
Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion

Detailed Description
-----------------
Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. They will rate their pain before and 30 minutes after the procedure using the ordinal categorical data on a numeric pain scale. Total patient opiate use will be gathered up to 8 hours after block completion.

Official Title
-----------------
Erector Spinae Regional Anesthesia for Pain Control in the Emergency Department

Conditions
-----------------
Pain Management

Intervention / Treatment
-----------------
* Drug: Bupivacaine Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Posterior/lateral rib or vertebral fractures Pancreatitis or pancreatic cancer Renal colic Back pain Exclusion Criteria: Unstable vitals Infection or open wound over insertion site Prior allergic reaction to local anesthetic Pregnant females Patients <18 years old Altered mentation

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
Interventional Model Description: Single group open label assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector Spinae Plane Block (ESP) administration<br>Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. | Drug: Bupivacaine Injection<br>* Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously<br>* Other names: Bupivacaine Hydrochloride Injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale Rating | Change in pain scale rating assessed by the participants on a scale from 0-10 with 0 indicating no pain and 10 indicating the most severe pain. | Baseline to study procedure end (approximately 30 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector spinae plane block, ESPB, Pain reduction
Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are: Superiority of total procedure time in remimazolam compared to midazolam The success of sedation time This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group

Official Title
-----------------
A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

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

Intervention / Treatment
-----------------
* Drug: Remimazolam
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who agreed for this clinical trials Patients who want diagnostic endoscopy under sedation The total procedure time which is predicted within 15 minutes ASA >=2 BMI more than 18.5kg/m2, less than 30kg/m2 Exclusion Criteria: Patients who have stomach illness Patients with respiratory disease Mallampati Score>=3 Systolic BP >160mmHg or <90mmHg Refractory Hypertension Uncontrolled glaucoma Severe liver failure or chronic kidney disease Patients with drug abuse or alcohol abuse within 1 year Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam) Obstructive sleep dyspnea patients Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Pregnant, breast feeding patient

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>The patient with midazolam | Drug: Midazolam<br>* The patient with midazolam<br>|
| Experimental: Remimazolam<br>The patient with remimazolam | Drug: Remimazolam<br>* The patient with remimazolam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time |  | begin when the drug is give to when the endoscopy is withdrawn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of sedation |  | Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose |
Study of CM310 in Patients With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

Detailed Description
-----------------
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Official Title
-----------------
A Multicenter, Single Arm Phase II Clinical Study Evaluating the Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-65. Understand the study and sign the Informed Consent Form voluntarily. Take effective contraception measures throughout the study period. Exclusion Criteria: Used other investigational drugs. Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310. Plan to participate in other studies during this clinical trial. With malignant or benign tumors of the nasal cavity. Other reasons the researcher believes that the subject is not suitable to participate in this study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM310<br>Subcutaneous injection | Biological: CM310<br>* IL-4Rα monoclonal antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence (including number of patients, events and percentage) of adverse events. | Week 12 |
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

Study Overview
=================
Brief Summary
-----------------
This is an observational study of the long term safety and efficacy of ICM-203.

Detailed Description
-----------------
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.

Official Title
-----------------
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Genetic: ICM-203
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous receipt of ICM-203 or matching placebo Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| ICM-203<br>Participants who previously received ICM-203 in ICM-203 clinical studies | Genetic: ICM-203<br>* Long term follow-up<br>|
| Placebo<br>Participants who previously received placebo in ICM-203 clinical studies | Drug: Placebo<br>* Long term follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delayed adverse events |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of total knee replacement |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adeno-associated virus, Gene therapy, ICM-203, Osteoarthritis
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.

Detailed Description
-----------------
Control group will receive US, TENS, IR and exercises. The treatment group will receive the same program in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks.

Official Title
-----------------
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial

Conditions
-----------------
Cervicogenic Headache

Intervention / Treatment
-----------------
* Other: Shock Wave Therapy
* Other: US, TENS, IR and exercises.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fifty patients from both genders. Age ranging from 20 to 40 years. Referred by an orthopedist with a diagnosis of Mechanical neck dysfunction (MND) to physical therapy at the outpatient clinic of the Faculty of Physical Therapy, MTI University. Exclusion Criteria: All other disorders.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The treatment group will receive US, TENS, IR and exercises in addition to shock waves therapy. Patients will receive 3 sessions per week for 4 weeks | Other: Shock Wave Therapy<br>* Receiving Shock wave therapy + US, TENS, IR and exercises.<br>* Other names: US, TENS, IR and exercises.;Other: US, TENS, IR and exercises.<br>* Receiving US, TENS, IR and exercises only.<br>|
| Experimental: Control Group<br>Control group will receive US, TENS, IR and exercises. Patients will receive 3 sessions per week for 4 weeks | Other: US, TENS, IR and exercises.<br>* Receiving US, TENS, IR and exercises only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Assess degree of pain | 4 weeks | 
| Neck disability index | Assess degree of neck disability. | 4 weeks | 
| Kinesiological EMG | Will be used for analysis of upper trapezius muscle functions in forms of root mean square and median frequency | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shock wave therapy, Trapezius trigger points, Cervicogenic headache
Standardising Care for Hepatitis Delta in the Netherlands

Study Overview
=================
Brief Summary
-----------------
Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection (hepatitis delta) has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary. Objective: Generate prospective follow-up data to increase our understanding of this rare disease. Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections

Official Title
-----------------
Standardising Care for Hepatitis Delta in the Netherlands

Conditions
-----------------
Hepatitis D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA test Patients must be ≥18 years Written informed consent Exclusion Criteria: None

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 |
| --- | --- |
| Hepatitis delta cohort<br>hepatitis delta patients aged ≥18 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective population based follow-up data | Generate prospective population based follow-up data of a homogeneously managed hepatitis delta cohort | 5 year |
Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC). The main questions it aims to answer are: If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC? If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy. There is not a comparison group in our study.

Official Title
-----------------
Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma, Magnetic Resonance Imaging, Neoadjuvant Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy Exclusion Criteria: Less than 10mm in the maximum diameter of the baseline primary tumor Poor MRI image quality with obvious metal or motion artifacts The failure to complete the course of neoadjuvant therapy
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 |
| --- | --- | --- |
| Comprehensive positive score | Comprehensive positive score for PD-L1 expression | 1 week before neoadjuvant therapy | 
| Pathological response | Postoperative pathological tumor residual status | 1 month after the last neoadjuvant therapy | 
| Change from maximum transverse tumor diameter after neoadjuvant therapy | Maximum transverse tumor diameter before and after neoadjuvant therapy | 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck squamous cell Carcinoma, Temporal diffusion spectroscopy imaging, Programmed death-ligand 1, Neoadjuvant therapy
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Detailed Description
-----------------
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones. Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system

Official Title
-----------------
Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones

Conditions
-----------------
Neonatal Jaundice

Intervention / Treatment
-----------------
* Device: Picterus JP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born with gestational age > 37 weeks. Birth weight ≥ 2500 grams Age 1 - 14 days Exclusion Criteria: Infants showing signs of inborn disease. Infants with skin rash or other skin disease that affects the skin where measurements are performed. Infants transferred to the pediatric ward for medical treatment. Infants that have received phototherapy in the last 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 14 Days

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: Repeatable bilirubin measurement independent of phone<br>all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera | Device: Picterus JP<br>* Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| jaundice screening | reproducible jaundice screening independent of smartphone used | 6 months |