cyrilzakka/clinical-trials huggingface dataset:
Tw HER2 Positive Breast Cancer Productivity & Utility Study

Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.

Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.

The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.

Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.

The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over;
* Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). \[HER2-positive is defined as IHC3+ and/or ISH≥2.0\]
* eBC patients should have received at least 2 cycles of adjuvant anti-cancer therapy following surgery at time of interview; metastasis breast cancer (mBC) patients should have received at least 1 cycle of treatment for their metastatic disease at time of interview.
* Able to provide written, informed consent.

Exclusion Criteria:

* Patients with ECOG performance status (PS) ≥3
* Unwilling or unable to provide written, informed consent
* Unable to complete written quality of life questionnaires
Influencer Marketing: a Survey-based Experiment Among Adolescents

Adolescents (N = 664) participated in the online survey-based experiment. They were randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or e-cigarette promotion alone (control). After watching each video, participants rated perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge) on the scale of 0 (e.g., dishonest) to 100 (honest).

Among all participants, harm perceptions and appeal of e-cigarettes was assessed. Susceptibility to use e-cigarettes was assessed among never users of e-cigarettes. These outcomes were then compared among participants who perceived influencers as credible and those who perceived influencers as non-credible.

Adolescents (13-17 years of age) living in California were recruited by Qualtrics marketing research panel to participate in a survey on tobacco-related attitudes and behaviors. Qualtrics, a research panel agency, has been used in prior research to survey adolescents about their tobacco-related attitudes and behaviors. Participants were provided with a survey URL link. After completing informed consent, participants completed the survey online. The study was approved by the University of Southern California Institutional Review Board (UP-21-00352). Respondents were randomly assigned to watch 10 10-second long TikTok videos in either experimental (influencers promoting e-cigarettes alongside healthy lifestyle activities) or control group (influencers promoting e-cigarettes alone).

Eligibility Criteria:
Inclusion Criteria:

* 13-17 years of age,
* English fluency,
* Current California resident.

Exclusion Criteria:

Not meeting these criteria:

* 13-17 years of age,
* English fluency,
* Current California resident.
How Does Skin Tone Affect Quantitative Photoacoustic Imaging

Photoacoustic imaging (PAI) is an emerging method which combines light and ultrasound to assess the blood content and oxygenation of the body. Light is absorbed by the blood, leading to the generation of ultrasound, from which the levels of oxygen can be derived. This high sensitivity to blood has seen it applied in multiple clinical trials for the assessment of a number of conditions including breast cancer assessment. However, the accuracy of the measurements and image quality is known to decrease as you look deeper into the body because light intensity decreases. Melanin in the skin is known to absorb light very strongly and so there is considerable concern that this may bias measurements made in people with darker skin tones compared to those with lighter skin tones. In this pilot study, we intend to recruit volunteers with a wide range of skin tones and vitiligo. We will scan a number of blood vessels and muscles using PAI and evaluate the photoacoustic measurements of blood content and oxygenation to identify, and ultimately correct for, biases in advance of further clinical studies.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary adult non-vulnerable participants between the age of 20 to 70.
2. Can understand the Information sheet and give informed consent in English.
3. Normal or Overweight BMI (18.5 to 29.9)

Exclusion Criteria:

1. No participants who cannot give informed consent.
2. No tattoos or scarring of the regions to be imaged.
3. No pulmonary sleep disorder, or active respiratory disorders that may affect the blood oxygenation levels.
Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* dietary therapy

Exclusion Criteria:

* lipid-lowering therapy
* anti-hyperglycemic drug therapy
Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata

The efficacy of two intralesional treatment modalities for alopecia areata will be determined. Thirty patients over the age of 6 with the diagnosis of alopecia areata on the scalp, with an extension of less than 50%, will be included. A comparison will be made between the effectiveness of intralesional Triamcinolone (standard first-line treatment) and intralesional Candida albicans antigen, with serial clinical and trichoscopic pictures at follow-up to evaluate the clinical response and associated adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of alopecia areata
* SALT score of less than 50% extension
* Has not received any topical or systemic treatment in the last month
* Signed informed consent

Exclusion Criteria:

* Any skin condition on the scalp (infectious, inflammatory or neoplastic) that could modify the clinical of trichoscopic features
* Pregnancy or breast-feeding
* Patients in medications that could cause hair loss as side-effects
The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System.

Randomized, two arms, controlled, open study comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the Care link treated group or non Care link treated group. At this segment of the study the usage of the Care link system will be accompanied by the diabetic team, through at least monthly contact via the Internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the Care link System, home-use, without support initiated by the diabetic team.

A randomized, two arms, controlled, open study in order to compare the efficacy, short and long term effects of regular home-use Vs diabetic team- supported use of the Medtronic CareLink therapy management system in patients with diabetes.

Primary objective:

To assess the efficacy, short term (4 months) and long term (8 months) effects of using the Medtronic CareLink® Therapy Management System for Diabetes on the following parameters:

1. Metabolic control as expressed by HbA1c.
2. Hypoglycemic events- number and severity of episodes.
3. DKA and ketosis events- number and severity of episodes.
4. Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires.
5. 7 points glucose profile.

Secondary objective:

To compare the efficacy of 4 months treatment using the CareLink® Therapy Management System, accompanied with intensive contact (at least once a month) initiated by diabetic team via the internet/electronic mail Vs home use treatment - without monthly contact initiated by the diabetic team

Study design:

The study will be comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the CareLink treated group or non CareLink treated group. At this segment of the study the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the CareLink system, home-use, without support initiated by the diabetic team.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes diagnosed at least 6 months prior to study entry
2. Current treatment with Medtronic 722 /712 external insulin pump systems
3. Treatment with insulin pump at least 3 month prior to study entry
4. An internet access from patient's home
5. Age 0-35 years old
6. HbA1c\>7.8
7. Signing inform consent forms

Exclusion Criteria:

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study
2. Patients participating in other device or drug studies
Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
* No contraindications in preoperative routine tests and examinations.
* Informed consent of patients.

Exclusion Criteria:

* Cervical radiculopathy
* Cervical kyphosis or instability
* Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
* Revision surgery or combined anterior-posterior surgery is required
* Serious neurological diseases affect the postoperative effect evaluation
* Mental illness cannot cooperate with follow-up
* Contraindications for MRI examination
* Patients themselves or their families do not agree to participate in the study
* Other situations that are not suitable for study participation.
Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids

The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 12 years of age
* treated with inhaled corticosteroids

Exclusion Criteria:

* Subjects with COPD or treatment for COPD
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.

B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with SOC antipsychotics and other psychotropic medications.

All doses will be administered twice daily, with approximately 12 hours between each dose.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with schizophrenia both male and female
2. Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
3. Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.

Exclusion Criteria:

1. History of seizure
2. Pregnant or nursing females
3. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
Chronic Myelod Leukemia Registry at Asan Medical Center

The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

1. Acquisition of informed concent form
2. Data acquisition from medical record including

   * demographic / disease-associated factors
   * details of treatment, and its results
   * complications during treatment
   * genetic data
   * survival outcome (upto 30 years)
3. Accumulation of data for 30 years
4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)

Eligibility Criteria:
Inclusion Criteria:

* All patients who are diagnosed and/or treated as chronic myeloid leukemia at Asan Medical Center
* 15 years of age and over
* All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria:

* Patients who refuse to give consent to registering
Identification and Therapy of Postpartum Depression

This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 4-6 weeks postpartum
* English-speaking
* Score of at least 10 on the Edinburgh Postnatal Depression Scale

Exclusion Criteria:

* DSM-IV diagnosis of bipolar disorder or psychotic episode
* Active substance abuse within 6 months prior to study entry
* Has not received obstetrical care
* History of a suicide attempt within 6 months of study entry
Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

The aim of this study is to determine and compare serum cytokine levels of six different severe asthma inflammatory phenotypes differentiated by their atopy, peripheral eosinophilia and/or chronic rhinosinusitis and/or nasal polyposis status.

A prospective observational study of 90 adults diagnosed with severe asthma and on regular follow-up and 15 control subjects will be investigated. Stable (controlled or partly-controlled) status (of all) and exacerbated-status (if any) serum cytokine levels \[IL-4, IL-5, IL-10, IL-13, IL-25, IL-33, thymic stromal lymphopoietin (TSLP), IL-17A, periostin) will be evaluated. Also nasopharyngeal brush samples will be obtained for respiratory tract panel work-up with PCR in exacerbated patients. Effect of viral infections' on cytokine response in different inflammatory phenotypes will be evaluated.

Eligibility Criteria:
Inclusion Criteria (for disease groups):

1. Patients diagnosed with severe asthma and followed-up at least 6 months at our clinic
2. Asthma that can only be complete or partly controlled with Global Initiative for Asthma (GINA) 4-5 treatment
3. Asthmatics that are eligible for the defined phenotypes
4. At least one perennial allergen sensitivity for the atopic groups

Inclusion Criteria (for control group):

1. Non-asthmatics (without clinical and pulmonary function test evidence)
2. Non-atopics (proved by skin prick tests)
3. Serum eosinophil count \<300/cells

Exclusion Criteria (for disease groups):

1. \<18 year-old
2. Smoking history within the last 1 year prior to the study
3. Asthmatics with inadequate inhaler technique and/or adherence problems
4. Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases
5. Organ transplantation history
6. Pregnancy
7. Other pulmonary problems: chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung diseases, pulmonary thromboemboli
8. During stable period investigation

   1. Asthma control test \<20
   2. Upper respiratory tract infections within 1 month before admission
   3. Exacerbation and/or systemic steroid use within 1 month before admission
9. Atopic patients that only have seasonal allergen sensitivity

Inclusion Criteria (for control group):

1. \<18 year-old
2. Smoking history within the last 1 year prior to the study
3. Asthmatics with inadequate inhaler technique and/or adherence problems
4. Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases
5. Organ transplantation history
6. Pregnancy
7. Other pulmonary problems: COPD, bronchiectasis, interstitial lung diseases, pulmonary thromboemboli
8. Without consent
Efficacy of T2259 in DED

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.


Eligibility Criteria:
Main inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection

Main exclusion Criteria:

* Far best-corrected visual acuity≤2/10
* Severe Blepharitis
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)

This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease
* Type 1 or type 2 diabetes
* HbA1c lower or equal to 11.0 %
* Body Mass Index (BMI) lower or equal to 40.0 kg/m2

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Current smoking or smoking within the last 6 months
* Other pulmonary disease including asthma
* Proliferative retinopathy or maculopathy requiring acute treatment