linjc16/ctgov huggingface dataset:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Study Overview
=================
Brief Summary
-----------------
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Detailed Description
-----------------
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Official Title
-----------------
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Conditions
-----------------
Anemia, Healthy, Pediatric ALL

Intervention / Treatment
-----------------
* Device: Rad-67 Pulse oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Greater than one month Weight: Greater than or equal to 3kg The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. Subjects deemed not suitable for the study at the discretion of the investigator Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc. Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test subjects<br>All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin. | Device: Rad-67 Pulse oximeter<br>* Noninvasive pulse oximeter that measures hemoglobin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of hemoglobin measurement | Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. | Up to 2 hours per subject |
Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder

Study Overview
=================
Brief Summary
-----------------
Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear network is known to be implicated in the pathophysiology of panic disorder. The fear network involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there is little information on how escitalopram affects the fear network. The specific aim of this study is to test the following hypotheses using 18F-FDG positron emission tomography (PET) Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects. Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram. The changes of fear work after the treatment will be associated with psychological variables and neurohormones.

Official Title
-----------------
Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: Lexapro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: panic disorder 20-60 years Exclusion Criteria: history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder. The acceptable score on the 17-item Hamilton Depression Rating Scale at entry into the study will be less than 17. patients and volunteers with alcohol dependence and current regular use of benzodiazepines will be excluded. Subjects with current or previous regular use of benzodiazepines will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>escitalopram (10-20mg) to panic patients | Drug: Lexapro<br>* 12 week treatment with lexapro<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18FDG-PET, PDSS & HAM-A |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panic disorder, PET, Escitaopram
Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is: To quantify the prevalence of adherence to topical mesalamine in patients with UC To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine

Detailed Description
-----------------
Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence. The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, Persistence Cohort. Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.

Official Title
-----------------
Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor must be receiving care at Beth Israel Deaconess Medical Center Exclusion Criteria: no diagnosis of ulcerative colitis no prescription for topical mesalamine not receiving care at Beth Israel Deaconess Medical Center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Prevalence of non-persistence amongst patients prescribed topical mesalamine for UC |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome (remission / relapse) at 12 months grouped by persistence status | Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score | 12 months | 
| Adherence phenotype details | Prevalence of self-reported low adherence amongst patients prescribed topical mesalamine Demographic and disease phenotype variables associated with non persistence or low adherence using multivariate logistic regression analysis | 12 months | 
| Quality-of-life score at 12 months | Short Inflammatory Bowel Disease Questionnaire score at 12 months | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis
Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies.

Official Title
-----------------
Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (ADHD)

Conditions
-----------------
Adult Attention-deficit/Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with newly diagnosed ADHD Exclusion Criteria: Known sensitivity to methylphenidate or any of the excipients Glaucoma Phaeochromocytoma During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis Hyperthyroidism or Thyrotoxicosis Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder. Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled) pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels) pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke a history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2-receptor blockers or in antacid therapy,

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) |  | 12-14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report |  | 12-14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Non-interventional study, Attention Deficit/Hyperactivity Disorder
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.

Official Title
-----------------
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance

Conditions
-----------------
Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Renal, Carcinoma, Small Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal, Carcinoma, Neuroendocrine, Carcinoma, Thymic, Carcinoma, Pancreatic, Carcinoma Breast, Carcinoma, Ovarian, Carcinoma Bladder, Carcinoma of Unknown Primary, Carcinoma of the Head and Neck, Carcinoma of the Oropharynx, Carcinoma of the Larynx, Carcinoma of the Bladder, Carcinoma of Esophagus, Carcinoma of the Nasopharynx, Carcinoma of the Penis, Carcinoma of the Cervix, Carcinoma of the Anus, Carcinoma of the Vulva, Carcinoma of the Appendix, Carcinoma of the Oral Cavity, Cholangiocarcinoma, Melanoma, Mesothelioma, Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥18 years of age Written Informed Consent provided by patient Diagnosis of any kind of carcinoma Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC Proceeding onto therapy for treatment Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088) Exclusion Criteria: Lack of informed consent Unable to obtain sufficient sample

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 |
| --- | --- | --- |
| BOR | Best overall response | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Lung Cancer, NSCLC, Occult Cancer, Ovarian Cancer, Melanoma, Mesothelioma, Gastrointestinal Stromal Tumor, Gastric Cancer, Colon Cancer, Cervical Cancer
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Study Overview
=================
Brief Summary
-----------------
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.

Detailed Description
-----------------
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement. The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated. The investigators plan to include 60 patients.

Official Title
-----------------
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Conditions
-----------------
Pulmonary Disease, Scleroderma, Systemic, Sleep Apnea, Obstructive

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known scleroderma diagnosis Must be able to give informed consent Exclusion Criteria: Serious neurological and/or psychiatric disease

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|Observational study. Intervention according to the clinical routines (not included in this part)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study | All participants will be evaluated within 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pulmonary involvement based on computer tomography findings | All patients will be evaluated within 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleroderma, sleep apnea, pulmonary disease
AZD1152 in Patients With Advanced Solid Malignancies-Study 1

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.

Official Title
-----------------
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: AZD1152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmation of a solid, malignant tumour At least measurable or non measurable site of disease as defined by modified RECIST criteria. Exclusion Criteria: Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug Treatment with radiotherapy/chemotherapy with 4 weeks of first dose Recent major surgery within 4 weeks prior to entry to the study

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD1152|2-hour continuous intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | Assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Assessed at predetermined timepoints after dose administration | 
| Effect on biomarkers |  | Assessed after treatment | 
| Anti-tumor activity |  | Assessed after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced solid tumors
Efficacy and Safety of Pitavastatin in a Real-world Setting

Study Overview
=================
Brief Summary
-----------------
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.

Detailed Description
-----------------
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.

Official Title
-----------------
Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets. Exclusion Criteria: Patients with hypersensitivity to pitavastatin Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in Patients with severe liver failure or biliary obstruction and patients with cholestasis Patients who are receiving cyclosporine Myopathy patients Pregnant women or women of childbearing age and lactating women Children Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose Patients deemed inappropriate by the investigator
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pitavastatin|1mg, 2mg, or 4mg, Once a day, at least 8 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as assessed by CTCAE v4.0 | Incidence of musculoskeletal-related adverse events and rhabdomyolysis | At 8 weeks after administration of pitavastatin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall symptom satisfaction evaluation | The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation | At 8 weeks after administration of pitavastatin | 
| Change in serum lipid profile before and after administration of pitavastatin | Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride | At screening and after 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LIVALO, Pitavastatin, Safety data, South Korea, Large-scale prospective trial