linjc16/ctgov huggingface dataset:
Dupilumab Phase 4 Study

Study Overview
=================
Brief Summary
-----------------
The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

Detailed Description
-----------------
The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Official Title
-----------------
Dupilumab Registry Study

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: Dupilumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care. Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD. Exclusion Criteria: Patients not on dupilumab Those who do not comply with the study requirements Those who do not provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dupilumab<br>Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care | Biological: Dupilumab<br>* Biologic (monoclonal antibody)<br>* Other names: Dupixent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantified Itch Survey |  | 1 to 3 months | 
| Quantified Sleep Survey |  | 1 to 3 months | 
| Quantified Quality of Life Survey |  | 1 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any AEs by 24 months | Will be determined based off of patient reported safety events | 24 months | 
| Occurrence of any infections by 24 months | Will be determined based off of patient reported safety events | 24 months | 
| Occurrence of any SAEs by 24 months | Will be determined based off of patient reported safety events | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis, dupilumab
Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Detailed Description
-----------------
Study design: an open-label randomized controlled trial Duration of study: 12 months Treatment arms: Denosumab: a total of 2 doses in a period of 12 months Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Official Title
-----------------
Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Denosumab
* Drug: Alendronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (women or men) >18 years of age Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months). Informed consent from patients. Willing to comply with all study procedures Exclusion Criteria: Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents. Premenopausal women who plan for pregnancy within 18 months of study entry. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism. Patients with unexplained hypocalcemia. Patients with serum creatinine level of >=200umol/L.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Denosumab<br>denosumab subcutaneous 60mg every 6 months | Drug: Denosumab<br>* active treatment group<br>* Other names: prolia;|
| Placebo Comparator: Alendronate<br>alendronate 70mg orally every week | Drug: Alendronate<br>* comparator<br>* Other names: fosamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density at lumbar spine | BMD lumbar spine | month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density at the hip | BMD hip | month 12 | 
| bone turnover markers | P1NP and osteocalcin | month 12 | 
| adverse events | adverse events | month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucocorticoids, steroids, osteoporosis
PACS System in the Training of Ophthalmologists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems).

Detailed Description
-----------------
In this randomized controlled clinical trial, we aim to explore the teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems) for doctors to master the specialized knowledge of orbital tumor.

Official Title
-----------------
Application of CBL Teaching Based on PACS System in Training of Ophthalmologists

Conditions
-----------------
Case Based Learning

Intervention / Treatment
-----------------
* Other: picture archiving and communication system
* Other: traditional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orbital diseases standardized training of doctors Willing to receive training Exclusion Criteria: Refuse to attend the assessment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACS group<br>PACS administration during teaching | Other: picture archiving and communication system<br>* PACS administration during teaching<br>* Other names: PACS;|
| Active Comparator: Traditional group<br>Traditional teaching without PACS | Other: traditional<br>* Clinical experience administration during teaching without PACS<br>* Other names: Clinical experience teaching;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination score | Examination score after training, with higher scores mean a better outcome. The highest score is 100. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teaching effect, teaching method
Mobile Health Technology for Palliative Care Patients

Study Overview
=================
Brief Summary
-----------------
To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.

Official Title
-----------------
Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status

Conditions
-----------------
Metastatic Cancer, Mobile Health, Chronic Disease

Intervention / Treatment
-----------------
* Device: Mobile Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess <12 months, > 8 weeks) Karnofsky Index ≥50% ECOG≤ 2 aged > 18 years passed a short handling test with devices (tracking bracelet, smart phone) Exclusion Criteria: relevant cognitive impairment insufficient knowledge of German language.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mobile Health|Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (time of complete data transfer in weeks) | time of complete data transfer in weeks | 12 weeks |
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome

Study Overview
=================
Brief Summary
-----------------
This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.

Official Title
-----------------
Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study

Conditions
-----------------
Infertility, Microbiome

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle; Female age: 20-45 years old; Single frozen-thawed blastocyst Transferred Endometrial thickness ≥7mm on the day of luteal transformation Written informed consent. Exclusion Criteria: Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease; Untreated hyperprolactinemia, thyroid disease, adrenal disease Antibiotic use within the past 7 days; Current or recent (within 3 months) drug abuse, including alcohol and tobacco; Refused or unable to comply with protocol requirements; Participation in any experimental drug study within 60 days prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conception positive<br>serum human chorionic gonadotropin ≥10 mIU/mL | Other: no intervention<br>* no intervention in this study<br>|
| Conception negative<br>serum human chorionic gonadotropin <10 mIU/mL | Other: no intervention<br>* no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of serum human chorionic gonadotropin ≥10 mIU/mL | Conception | 09.01.2022 to 09.01.2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | detection of a gestational sac in the uterine cavity 3 weeks after conception | 09.01.2022 to 09.01.2024 |
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured. Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract. This study, as an exploratory trial, does not required statistical hypothesis.

Official Title
-----------------
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Other: Mulberry fruit extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight) Give written informed consent and voluntarily decide participation Exclusion Criteria: Acute or chronic disease symptom on screening Existing active and clinically significant disease involving more than one organ system Known allergy to Mulberry or other berries Positive drug or alcohol screening Smokers of 10 or more cigarettes per day Participation in a clinical trial during last 2 month prior to the start of the study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mulberry fruit extract<br>Daily 1000 mg oral Mulberry fruit extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1. | Other: Mulberry fruit extract<br>* 1000 mg oral daily dose for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration - C3G in Plasma |  | Blood samples collected over 6 hours | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma |  | Blood samples collected over 6 hours | 
| Antioxidative markers |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | for 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C3G, Oxidative stress, Antioxidant, Mulberry
Prediction to Detect Pre-DM/DM in a Chinese Population

Study Overview
=================
Brief Summary
-----------------
This project will compare the sensitivity and specificity of different screening criteria or recommendations to detect pre-diabetes or diabetes mellitus in a Chinese population, using point-of-care hemoglobin A1c.

Official Title
-----------------
Sensitivity and Specificity of Guidelines' Recommendations and Existing Predictive Models to Detect Undiagnosed Diabetes Mellitus or Prediabetes in a Chinese Population

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: point-of-care HbA1c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥25 years old with no previous diagnosis of DM Chinese. Exclusion Criteria: a history of cardiovascular diseases including any type of stroke, ischemic heart disease, atrial fibrillation, and/or peripheral vascular disease severe mental or physical disease or language barriers that limited data collection

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Chinese people with no known history of diabetes<br> | Diagnostic Test: point-of-care HbA1c<br>* The Afinion2™ (Abbott, Oslo, Norway), will be used for the current study as it is recently validated. According to American Diabetes Association (ADA), pre-diabetes (pre-DM) is diagnosed if HbA1c is 5.7-6.4% and diabetes (DM) is diagnosed if HbA1c is ≥6.5%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point-of-care (POC) HbA1c | the measurement to diagnose pre-diabetes or diabetes; pre-DM is diagnosed if HbA1c is 5.7-6.4% and DM is diagnosed if HbA1c is ≥6.5%. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office blood pressure | a measurement to screen for hypertension; BP will be measured for 2 times (1-minute apart) and will be in accordance to the Hong Kong Primary Care Office guideline (e.g. the choice of cuffs and positioning). The average of the two BP readings will be used for analysis and management. Elevated BP is defined as a systolic BP (SBP) of ≥140mmHg and/or a diastolic BP (DBP) ≥90mmHg | baseline | 
| Body mass index | a measurement for obesity. Body mass index (BMI) is calculated by weight divided by the square of height (BMI = weight (kg)/height(m)2). According the Hong Kong Centre for Health Protection, overweight and obesity are defined as a BMI of 23-24.9kg/m2 and ≥25kg/m2 respectively | baseline |
Reference Intervals for Sonoclot Analysis in Chinese

Study Overview
=================
Brief Summary
-----------------
The reference intervals for Sonoclot Analysis may be different between Chinese and American. So far, no reference interval has been established in Chinese for Sonoclot Analysis. This study is going to establish the first Chinese reference intervals for Sonoclot Analysis and test whether they are different from American reference intervals.

Official Title
-----------------
Reference Ranges for Sonoclot Analysis in Chinese

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 and older Han ethnic Exclusion Criteria: Renal dysfunction Liver disorders Known coagulation disorders Patients taking medications in the last month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 reference intervals for sonoclot analysis in Chinese | whether Chinese reference intervals are different from Caucasian reference intervals. | 3 month |