linjc16/ctgov huggingface dataset:
Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.

Official Title
-----------------
Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Pulse Oximeter with respiration rate sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 0 to 5 years old Fully developed skin Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that would interfere with sensor application. Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI). Subjects deemed not suitable for the study at the discretion of the investigator

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate. | Device: Pulse Oximeter with respiration rate sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of high-resolution pulse oximetry and RAM data in pediatric subjects | The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population. | through study completion, an average of 6 months |
Pergolide Treatment for Substance Abusers - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine dependence.

Official Title
-----------------
Pergolide Treatment for Substance Abusers

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Craving |  |  | 
| Drug use |  |  | 
| Improvement in functioning |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Orthopaedic Hand Service Data Repository

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion). The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.

Official Title
-----------------
Orthopaedic Hand Service Data Repository

Conditions
-----------------
Non-traumatic and Traumatic Health Issues

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Patients presenting to Hand Service for traumatic or non-traumatic issues. English Speaking Exclusion Criteria: under 18 years vulnerable population

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Escort<br> | |
| Hand Service patient<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL

Study Overview
=================
Brief Summary
-----------------
Multi-center retrospective analysis of patients with DLBCL aged ≥80 years old treated with R-CHOP-14 compared to other regimens. Patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. Relative dose intensity (RDI) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. Primary endpoints are overall (OS), progression-free (PFS) and event-free survival (EFS), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.

Official Title
-----------------
Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL

Conditions
-----------------
Old Age; Debility, DLBCL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven, untreated diffus large B-cell lymphoma (DLBCL) diagnosis between 2005 - 2019 age ≥80 at diagnosis Exclusion Criteria: - diagnosis revision at a later timepoint

Ages Eligible for Study
-----------------
Minimum Age: 80 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 |
| --- | --- |
| R-CHOP-14<br> | |
| R-mini-CHOP<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation. | time from diagnosis to death | through study completion, an average of 2 years | 
| Progression-free survival (PFS) | time from diagnosis to death or progression/relapse | through study completion, an average of 2 years | 
| Event-free survival (EFS) | defined as time from diagnosis to death or progression/relapse or treatment discontinuation. | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Dose intensity | Percentage of the dose intensity achieved divided by the intended dose intensity | within the treatment period, up to 36 weeks |
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.

Official Title
-----------------
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Ophthalmologic examinations
* Drug: Ivacaftor Exposed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 11 years of age or younger at the time of treatment initiation with ivacaftor (as part of clinical trial) or commercially-available ivacaftor. Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor. Exclusion Criteria: Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol. Subject has received surgery for cataracts

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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 |
| --- | --- |
| Ivacaftor Treated<br> | Other: Ophthalmologic examinations<br>* Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.<br>Drug: Ivacaftor Exposed<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cataracts (lens opacities) |  | Through Month 24 | 
| Best corrected distance vision |  | Through Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis
the Effect Between Platelet Reactivation and Antiplatelet Drugs

Study Overview
=================
Brief Summary
-----------------
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.

Detailed Description
-----------------
All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period. Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.

Official Title
-----------------
Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.

Conditions
-----------------
Drug Effect Disorder, Platelet Procoagulant Activity Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease, percutaneous coronary intervention Exclusion Criteria: high risk bleeding patient, allergic to the drugs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ticagrelor2<br>Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day | |
| Ticagrelor1<br>Ticagrelor with a dose of 90mg followed by 90 mg twice per day . | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity | LTA and TEG used to measure the effect of Platelet reactivity | 1 year |
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.

Detailed Description
-----------------
post marketing surveillance none

Official Title
-----------------
An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study

Conditions
-----------------
Vasomotor Symptoms, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: desvenlafaxine succinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate Exclusion Criteria: Hypersensitivity to desvenlafaxine succinate

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 |
| --- | --- |
| 1<br> | Drug: desvenlafaxine succinate<br>* 50 mg tablet once daily<br>* Other names: Pristiq;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state. | Week 4 to Week 8 | 
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. |  | Week 4 | 
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. |  | Week 8 | 
| Change From Baseline in Heart Rate at Week 4. |  | Week 4 | 
| Change From Baseline in Heart Rate at Week 8. |  | Week 8 | 
| Change From Baseline in Weight at Week 4. |  | Week 4 | 
| Change From Baseline in Weight at Week 8. |  | Week 8 |
Effects of Physical Exercise in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.

Official Title
-----------------
Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedentary adult with type 2 diabetes BMI between 25 and 35 kg/m² Hba1c < 10 % Exclusion Criteria: unstable coronary artery disease advanced peripheral occlusive arterial disease proteinuria > 3 g/d and / or creatinine clearance < 30 ml / mn advanced diabetic neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical exercise<br>Physical exercise | Behavioral: Physical exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.

Official Title
-----------------
A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.

Conditions
-----------------
Allergy, Infections

Intervention / Treatment
-----------------
* Other: Self-administered questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible to participate in the TEMPO Follow-Up study in case: they completed the final (12 months) visit in the TEMPO study. parents agree that their contact details will be shared with a third party for study purposes. parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study. parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law. Exclusion Criteria: Parents who do not have a smartphone, tablet or personal computer with internet access.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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 |
| --- | --- |
| Children who participated in randomised clinical trail, called TEMPO, in their first year of life<br>Children who participated in randomised clinical trail, called TEMPO, in their first year of life | Other: Self-administered questionnaires<br>* Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-reported symptoms of allergies and infections | The occurrence of parent-reported - symptoms suggestive of allergies and infections | 7.5 years | 
| Parent-reported use of medications and/or a medical device | The occurrence of parent-reported - use of medications and/or a medical device to prevent or relieve symptoms suggestive of allergies and infections | 7.5 years | 
| Parent-reported - hospitalisations and visits to the emergency room | The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections | 7.5 years |
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.

Official Title
-----------------
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

Conditions
-----------------
Breast Cancer, Quality of Life

Intervention / Treatment
-----------------
* Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 0-III breast cancer Exclusion Criteria: Stage IV breast cancer Breast cancer recurrence or metastasis Severe medical illness

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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: Distress screening group<br>Physical activities will be monitored by wearable device. Patient-reported outcomes including distress, depression, physical activities and quality of life are going to be collected by questionnaires based on smartphone application and paper. The algorithm of distress screening will be developed with the analysis of patterns of physical activities. | Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)<br>* Physical activities will be monitored by wearable device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of distress screening of wearable device | The results of distress screening questionnaire and patterns of physical activities are going to be compared. The association between those two data will be analyzed. Using data of physical activities, the prediction model of distress will be tested and validated. | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distress, Exercise, Wearable device, Smartphone