linjc16/ctgov huggingface dataset:
Public Perception and Attitude of Chinese Towards Biomedical Research and Biobanking in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect date related to public knowledge and attitude towards biospecimen-based research and their willingness to participate in biobanking in China.

Official Title
-----------------
Public Perception and Attitude of Chinese Towards Biomedical Research and Biobank in China

Conditions
-----------------
Public Knowledge and Attitude Towards Biospecimen-based Research and Their Willingness to Participate in Biobanking

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals aged 18 years and above could understand the content of the questionnaire and express themselves voluntary to participate in this survey Exclusion Criteria: history of mental illness or the deaf not able to express their views and opinions clearly

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: no intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure public knowledge of biobanking and biospecimen-based research with self-complied questionnaire |  | 4 months | 
| measure public attitude towards biobanking and biospecimen-based research with self-complied questionnaire |  | 4 months | 
| measure public willingness to participate in biobank with self-complied questionnaire |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biobanking, research participation, China
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems

Study Overview
=================
Brief Summary
-----------------
The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.

Official Title
-----------------
MyCompass in a Swedish Context - Lessons Learned From the Transfer of an Automated Self-help Intervention Targeting Mental Health Problems

Conditions
-----------------
Mild Depression, Anxiety State, Sleep Disturbance, Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: MyCompass
* Behavioral: Comparison group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Swedish resident Valid e-mail address 18 years old or older PHQ-9 score of 5-20 GAD-7 score of 5-15 Exclusion Criteria: suicidal thoughts

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group receives the MyCompass intervention, an automated self-help intervention for mild to moderate mental ill-health. | Behavioral: MyCompass<br>* Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.<br>|
| Placebo Comparator: Comparison group<br>The control group receives a brief email each week, describing the most common mental health issues. | Behavioral: Comparison group<br>* An email containing a brief text on general tips regarding mental health was sent out once a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | Self-report measure on depressive symptoms. Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score, where a higher score indicates more severe depression. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe and severe depression, respectively. For the purpose of this study, participants with a score between 5-20 were included. | 2 weeks | 
| Generalised Anxiety Disorder 7-item scale (GAD-7) | Self-report measure on anxiety symptoms. Seven items with score 0-21, a higher score indicating more severe anxiety. Cutoffs: Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. For the purpose of this study, participants with a score between 5-15 were included. | 2 weeks |
A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

Study Overview
=================
Brief Summary
-----------------
This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab

Official Title
-----------------
Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adult male or female (≥18 years of age) patients with NSCLC Treated with nivolumab on the Australian PAP Initiated Nivolumab between May 2015 and August 2017 Attending clinician agreeable to provide patient data Local institutional ethics requirements satisfied Exclusion Criteria: Insufficient data available Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Patients taking nivolumab<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (TTF) |  | Approximately 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response (BOR) |  | Approximately 27 months | 
| Progression free survival rate (PFSR) |  | Approximately 27 months | 
| Overall survival rate (OSR) |  | Approximately 27 months | 
| Incidence of AE's |  | Approximately 27 months | 
| Incidence of SAE's |  | Approximately 27 months | 
| Reasons for ceasing treatment | Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death | Approximately 27 months | 
| Incidence of patients with brain metastases |  | Approximately 27 months | 
| Incidence of re-treatment |  | Approximately 27 months |
Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

Study Overview
=================
Brief Summary
-----------------
Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.

Detailed Description
-----------------
the objective is to produce a collection of great scientific interest for lymphoma research from CELESTIMO's clinical trial patients' samples to increase knowledge of treatment with mosunetuzumab's for patients with follicular lymphoma (FL). study population involves patients participating to CELESTIMO study in France. 10 sites are expected in this biobanking protocol study Biological samples will collected as part of routine care (tissue and blood already sampled in routine and/or CELESTIMO study) at screening, at C4, at C12 or at progressive disease/relapse.

Official Title
-----------------
Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

Conditions
-----------------
Follicular Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
patients who participate to CELESTIMO study (NCT04712097)

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 |
| --- | --- | --- |
| Capacity of sampling | number of samples collected | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance, CD20-CD3, Bispecific antibodies, Neoplasms, Lymphatic Diseases, Immunoproliferative Disorders, Follicular Lymphoma, Mosunetuzomab
Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Conditions
-----------------
Vision

Intervention / Treatment
-----------------
* Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)
* Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)
* Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 35 Body Mass Index (BMI) 21-27 kg/m2 Must be able to give written informed consent Subjects must be willing to comply with all study requirements. Subjects must understand, sign and be given a copy of the written Informed Consent form. Exclusion Criteria: Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria Subjects who are pregnant, lactating or planning to be pregnant during the course of the study Subjects with known sensitivity to planned study concomitant medications Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICAPS AREDS Softgel Capsule - Full Strength<br>ICAPS Eye Vitamin and Mineral Supplement - Softgel | Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)<br>* Single full strength dose capsule taken one time<br>|
| Experimental: ICAPS AREDS Softgel Capsule - Half Strength<br>ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength) | Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)<br>* Single half strength dose capsule taken one time<br>|
| Experimental: ICAPS AREDS coated tablets - Full Strength<br>ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets | Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)<br>* Single, full strength dose tablet taken one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of nutrients |  | 1 week for each treatment cross-over period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, Ocular Vitamins
The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

Detailed Description
-----------------
The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWP16001
* Drug: DWP202010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: DWP16001 A mg<br> | Drug: DWP16001<br>* DWP16001 A mg<br>|
| Experimental: Intervention: DWC202010 B mg<br> | Drug: DWP202010<br>* DWP202010 B mg<br>|
| Experimental: Intervention: DWP16001 A mg + DWC202010 B mg<br> | Drug: DWP16001<br>* DWP16001 A mg<br>Drug: DWP202010<br>* DWP202010 B mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax,ss) of DWP16001 |  | Before IP administration of Day 1, Day 5, and Day 6 | 
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 |  | Before IP administration of Day 1, Day 5, and Day 6 | 
| Peak Plasma Concentration (Cmax,ss) of DWC202010 |  | Before IP administration and post-dose up to 24 hours | 
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 |  | Before IP administration and post-dose up to 24 hours |
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

Study Overview
=================
Brief Summary
-----------------
The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs. This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME

Detailed Description
-----------------
Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily teriparatide sc for three months or placebo. MRI examinations at baseline and after three months will be performed. Serum bone turnover markers will be evaluated as well as QoL questionnaires.

Official Title
-----------------
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

Conditions
-----------------
Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life

Intervention / Treatment
-----------------
* Drug: Denosumab
* Drug: Teriparatide
* Drug: Placebo Denosumab
* Drug: Placebo Teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI diagnosed bone marrow edema Exclusion Criteria: any prior antiresorptive or osteoanabolic treatment any prior therapy with strontium ranelate Hyper-/hypocalcemia malignancies pregnancy and contraindication against denosumab or teriparatide

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teriparatide<br>daily subcutaneous injection of teriparatide 20µg for three months | Drug: Teriparatide<br>* daily subcutaneous injection of teriparatide<br>* Other names: PTH 1-34;|
| Placebo Comparator: Placebo Teriparatide<br>daily subcutaneous teriparatide placebo injection | Drug: Placebo Teriparatide<br>* daily subcutaneous placebo injection<br>* Other names: PTH 1-34;|
| Active Comparator: Denosumab<br>one subcutaneous injection of denosumab | Drug: Denosumab<br>* sc RANKL-inhibitor<br>* Other names: Prolia;|
| Active Comparator: Placebo Denosumab<br>one subcutaneous injection of denosumab placebo | Drug: Placebo Denosumab<br>* one subcutaneous injection denosumab placebo<br>* Other names: Prolia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs | MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score | baseline - month 1 - month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow edema, denosumab, PTH 1-84
Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients

Study Overview
=================
Brief Summary
-----------------
There is a decline in androgen concentration with ovarian aging. Also, ovarian response to COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian androgen concentration. A physiological way to induce androgen synthesis within the ovary is to stimulate theca cells androgen production by hCG stimulation. By doing this in the previous cycle we might expect a better response to COH.

Official Title
-----------------
hCG Priming Prior to COH in Poor Responder IVF Patients

Conditions
-----------------
Ovarian Response

Intervention / Treatment
-----------------
* Biological: human chorionic gonadotropin
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved Exclusion Criteria: 42 years or older BMI <18 or >30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

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

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 |
| --- | --- |
| Active Comparator: hCG<br>200 IU rec hCG s.c./5 days, 4 doses prior to onset of COH | Biological: human chorionic gonadotropin<br>* 200 IU, sc, every 5 days, 4 doses<br>Biological: placebo<br>* diluent, every 5 days, s.c., 4 doses<br>|
| Placebo Comparator: placebo<br>similar injection at same time points with similar diluent but no hCG | Biological: placebo<br>* diluent, every 5 days, s.c., 4 doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | 2 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved |  | 2 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgens, hCG, low response, IVF, Ovarian response in women with previous low response
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea Before and After Treatment With CPAP.

Study Overview
=================
Brief Summary
-----------------
We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Continuous Positive Airway Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 65 years Obstructive sleep apnea Hypertension or normal blood pressure Exclusion Criteria: Drug or alcohol abuse Pregnancy History or clinical signs of disease in the heart, lungs, brain,liver, kidneys or endocrine organs Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous Positive Airway Pressure|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
-----------------
Obstructive sleep Apnea, Hypertension, Vasoactive hormones