linjc16/ctgov huggingface dataset:
Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

Study Overview
=================
Brief Summary
-----------------
This project expects to enroll 60 cancer patients, 60 healthy people and their subjective-objective measurements on fatigue, stress, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.

Official Title
-----------------
Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

Conditions
-----------------
Cancer-Related Condition

Intervention / Treatment
-----------------
* Device: smart bracelet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≧ 20 years old; One group had a cancer diagnosis, one group no cancer diagnosis; Can continuous wearing bracelet for 5 days or more Exclusion Criteria: Unclear and unable to answer the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Cancer patient<br>This project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed. | Device: smart bracelet<br>* to measure the stress, fatigue, and activity.<br>|
| Healthy population<br>This project expects to enroll 60 healthy population and their subjective-objective measurements on fatigue, stress, and total steps will be observed. | Device: smart bracelet<br>* to measure the stress, fatigue, and activity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index | over 5 days | 
| Heart Rate Variability (HRV) monitor | Use a digital device to measure the heart rate variability and calculate the HRV data | over 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress Thermometer(DT) | a screening measure to identify and address psychological distress in individuals with cancer. a cutoff score of 3 on the DT to indicate patients with clinically elevated levels of distress. | over 5 days | 
| Leeds Sleep Evaluation Questionnaire(LSEQ） | To assess sleep quality, higher scores mean more disrupt sleep. | over 5 days | 
| International Physical Activity Questionnaire(IPAQ） | Life activity survey | over 5 days | 
| Perceived Stress Scale (PSS） | higher scores mean more stressful condition | over 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer-related fatigue, smart bracelet device
Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly. II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH hypersecretion.

Detailed Description
-----------------
PROTOCOL OUTLINE: Growth hormone-releasing hormone antagonist (GHRH-A) is administered to volunteers and followed with 1 of these challenges: insulin, clonidine, pyridostigmine, arginine, levodopa, growth hormone-releasing peptide, or exercise. Tests are repeated with normal saline as the control; the order of administration (control vs. pharmacologic stimulation) is randomly assigned. Patients receive GHRH-A (dose determined in volunteer study), thyrotropin-releasing hormone, and growth-releasing hormone. All stimulation tests follow an overnight fast.

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Active acromegaly with growth hormone (GH) hypersecretion confirmed within 1 month prior to entry, i.e.: Somatomedin C elevated GH not below 2 ng/mL on standard 100 g oral glucose tolerance test Postmenopausal and hypogonadal women eligible Volunteers aged 18 to 30 recruited for up to 3 stimulation tests Weight within 15% of ideal Physical exam normal No history of disease No requirement for medication No medical or mental contraindication to protocol participation, including heavy alcohol or tobacco use No pregnant women --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 18 to 65 Hematopoietic: No anemia Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No uncontrolled hypertension No heart disease Other: No requirement for replacement gonadal steroids, glucocorticoids, or thyroxine No mental illness No heavy alcohol use No tobacco use No drug abuse No medical contraindication to protocol therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromegaly, endocrine disorders, rare disease
Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

Detailed Description
-----------------
Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. We hypothesize that trained monocytes augment atherogenesis. Objective: The main objective is to study whether patients with coronary atherosclerosis show specific epigenetic changes in the promoter regions of pro-inflammatory cytokines and chemokines and whether this correlates with the inflammatory phenotype of these cells. Study design: Observational study Study population: Adult patients who have had computed tomography coronary angiography because of chest pain: 20 patients without atherosclerosis and 20 patients with severe atherosclerosis will be included.

Official Title
-----------------
Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (male/female), aged >18 years, admitted to the acute coronary unit of the CWZ hospital for evaluation of chest pain. No coronary atherosclerosis Or Severe atherosclerosis Exclusion Criteria: Signs or symptoms of a current infection (fever, chills) Auto-immune diseases (such as rheumatoid arthritis)

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<br>patients with documented atherosclerosis on a CCTA | |
| controls<br>patients without atherosclerosis on a CCTA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic modifications in circulating monocytes |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory phenotype |  | baseline |
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis

Study Overview
=================
Brief Summary
-----------------
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.

Official Title
-----------------
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction

Conditions
-----------------
Mammoplasty

Intervention / Treatment
-----------------
* Device: Fortiva® 1mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 years or older A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral) Estimated life expectancy > 2 years Able and willing to return for all scheduled and required study visits Able to provide written informed consent for study participation Able to read, understand and complete study questionnaires Exclusion Criteria: Any of the conditions listed in the approved labeling as contraindicated Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study Any patient that per the physician's judgement is not a good candidate for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: post market prospective, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perforated<br>Fortiva® 1mm perforated ADM | Device: Fortiva® 1mm<br>* Post mastectomy immediate reconstruction<br>|
| Active Comparator: Non-perforated<br>Fortiva® 1mm non-perforated ADM | Device: Fortiva® 1mm<br>* Post mastectomy immediate reconstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Fortiva® tissue matrix | Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events. | 24 months | 
| Performance of Fortiva® tissue matrix | • Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey. | 24 months |
Quality of Sexual Function in BRCA Mutated Women

Study Overview
=================
Brief Summary
-----------------
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.

Detailed Description
-----------------
We aim to investigate and compare the impact of diagnosis of BRCA, the impact of risk reducing surgery (RRS) and oncological diagnosis.

Official Title
-----------------
Quality of Sexual Function in BRCA Mutated Women

Conditions
-----------------
BRCA Mutation, Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological

Intervention / Treatment
-----------------
* Other: SFQ28 Questionnaire


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BRCA Mutated and no RRS<br> | Other: SFQ28 Questionnaire<br>* SFQ28 Questionnaire<br>|
| BRCA Mutated and RRS<br> | Other: SFQ28 Questionnaire<br>* SFQ28 Questionnaire<br>|
| BRCA Mutated and oncological diagnosis<br> | Other: SFQ28 Questionnaire<br>* SFQ28 Questionnaire<br>|
| BRCA Wildtype without oncological diagnosis<br> | Other: SFQ28 Questionnaire<br>* SFQ28 Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of SFQ28 Score |  | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brca, sexual
Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.

Official Title
-----------------
An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Conditions
-----------------
Lymphoid Malignancies

Intervention / Treatment
-----------------
* Drug: Idelalisib


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit Evidence of a personally signed informed consent Key Exclusion Criteria: Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib Toxicities that would preclude initiating therapy with idelalisib prior to enrollment Concurrent participation in another therapeutic clinical trial Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days. Note: Other protocol defined Inclusion/ Exclusion criteria may 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idelalisib<br>Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs. | Drug: Idelalisib<br>* Idelalisib 150 mg tablet administered orally twice daily<br>* Other names: Zydelig®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction. | Up to Day 602 plus 30 days |
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 is involved in headache pathophysiology.

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Drug: PGI2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, Exclusion Criteria: Primary headache, headache on the day of investigation, Hypertension, hypotension, pregnant/nursing Daily intake of medication (except oral contraceptives) Cardiovascular or CNS disease Drug/Alcohol abuse Psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PGI2|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rCBF, blood flow, diameter of STA/RA, HR, BP |  |  |
Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.

Official Title
-----------------
Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer

Conditions
-----------------
Metastatic Colon Cancer

Intervention / Treatment
-----------------
* Drug: [89Zr]Panitumumab PET-MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 19 years of age. Diagnosis of colon cancer Scheduled to undergo surgical resection Exclusion Criteria: Inability to provide informed consent Pregnancy Inability to lie still for the imaging study Weight over 350 lbs., due to the scanner bore size Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos) Inability to receive Omnipaque (iohexol) iodinated contrast Inability to receive glucagon Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent Allergy to contrast imaging agents Finding or suspicion of distant metastases on CT

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

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

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

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 |
| --- | --- |
| Experimental: [89Zr]Panitumumab-PET/MRI patients<br>All study patients will receive [89Zr]Panitumumab-PET/MRI imaging. | Drug: [89Zr]Panitumumab PET-MRI<br>* All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Diagnostic image quality of [89Zr]Panitumumab PET imaging in patients with newly diagnosed colon cancer with nodal involvement. Standardized Uptake Values (SUVs) will be measured. | 12 months |
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

Study Overview
=================
Brief Summary
-----------------
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients. This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.

Official Title
-----------------
A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.

Conditions
-----------------
Rash Due to Epidermal Growth Factor Receptor Inhibitors

Intervention / Treatment
-----------------
* Drug: RECONVAL CREAM
* Drug: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic colon cancer patients male or female age> 18 treated EGFRI Exclusion Criteria: prior treatment with EGFRI

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECONVAL CREAM<br>half face treated with RECONVAL CREAM | Drug: RECONVAL CREAM<br> <br> |
| Placebo Comparator: PLACEBO<br>half face treated with PLACEBO cream | Drug: PLACEBO<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI | Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFRI, COLON CANCER, SKIN TOXICITY, RECONVAL K1 cream