linjc16/ctgov huggingface dataset:
Accuracy of Point-of-Care Measurement With the RapidPoint 500 Blood Gas Analyser

Study Overview
=================
Brief Summary
-----------------
ICU patients are at high risk of ionic or metabolic disturbances during the course of their critical illness. Some of these disturbances might be life-threatening and require rapid response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid and appropriate therapy. This technology has largely improved the quality of care in ICU. However, the accuracy of the measurement of those parameters had to be close enough to the reference method, usually perfomed in the central lab but time consuming. Recently, a novel generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted with a 28-day cartridge which provides automatic calibrations and quality controls several times a day. Such a technology dramatically decreases the need for labs technical interventions. To date, there is no data reporting the accuracy of this device. Therefore, the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and Beckman&Coulter DXH for hemoglobin).

Official Title
-----------------
Accuracy of Point-of-Care Measurement of Electrolytes, Glucose, Hemoglobin and Hematocrit With the RapidPoint 500 Blood Gas Analyser

Conditions
-----------------
Critical Care, Electrolytes, Point-of-Care Systems

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current stay in ICU Presence of an indwelling arterial catheter (radial or femoral) Prescription by physicians of a blood gas analysis and a laboratory analysis for the next morning Exclusion Criteria: None

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 |
| --- | --- | --- |
| bias and limit of agreement | to describe the bias and limit of agreement between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit. | 1 month | 
| Dumming regression analysis | to describe the relation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit. | 1 month | 
| Coefficient of correlation (Pearson) | to describe the correlation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit. | 1 month |
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)

Study Overview
=================
Brief Summary
-----------------
This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.

Official Title
-----------------
A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients

Conditions
-----------------
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
-----------------
* Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has ovarian, primary peritoneal, or fallopian tube cancer Patient has first or subsequent relapse Patient has had at least on prior platinum-based treatment for ovarian cancer Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum Patient is not pregnant Exclusion Criteria: Patient has had abdominal surgery within the last 6 weeks Patient has life expectancy < 6 months Patient has had radiotherapy to the abdomen or pelvis within the last 6 months Patient has poorly controlled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>18-F-FDG PET/CT imaging | Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT<br>* Patients will receive standard-of-care therapy (carboplatin or cisplatin monotherapy, or a two-drug combination where one is platinum). FDG-PET/CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, and if patients are progression-free at the end of Cycle 6. Volumetric CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, after Cycle 3 of chemotherapy (optional), and if patients are progression-free at the end of Cycle 6 and at 40 weeks after Cycle 1 dosing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy |  | Baseline, Week 3, Week 6 | 
| Progression free proportion |  | 40 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed ovarian cancer
Continuous Deep Sedation Until Death

Study Overview
=================
Brief Summary
-----------------
This research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in France. All data collected is part of the patient record. The main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.

Detailed Description
-----------------
All participating sites will include last 10 consecutive major patients deceased following a decision to limit or stop therapeutics. The study include only data from patients died before January 1, 2020. In the case report form the following information will be entered: the characteristics of the unit of intensive care or continuing care unit. Patient Characteristics Characteristics of sedative practices

Official Title
-----------------
Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units

Conditions
-----------------
Terminal Care

Intervention / Treatment
-----------------
* Other: NO INTERVENTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients at the time of death (>18years) Died in intensive care or in continuing care unit Patient died before January 1st, 2020. Patients deceased following a decision to limit or stop therapeutics Exclusion Criteria: Patients who died of brain death or unexpected cardiac arrest at death of unsuccessful cardiopulmonary resuscitation Patient who expressed during his lifetime his opposition to the use of his data for scientific research

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 deceased following a decision to limit or stop therapeutics<br>a | Other: NO INTERVENTION<br>* observational study, no intervention performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of end-of-life sedative practices | Information concerning end-of-life sedative practices are recorder in the CRF (treatments used, patient's and unit characteristics...) | after patient death (before january 1st 2020) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Limit or Stop Treatment in Intensive Care, Continuous deep sedation (CDS), Continuous deep sedation until death (CDSUD)
Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes. DESIGN. Randomized trial of 20-week aquatic classes. SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)

Official Title
-----------------
Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis

Conditions
-----------------
Osteoarthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically confirmed diagnosis of osteoarthritis from a physician Aged 55 to 75 Not currently exercising, defined as engaging in an average of less than 60 minutes of exercise/week during the last month Permission of the subject's primary physician to participate in the aquatic class Not currently enrolled in another medical study Not scheduled for joint replacement surgery during the study period Living in an area where Arthritis Foundation aquatic programs were offered Willingness to be randomized and to commit to the 5-month study period

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Community-based aquatic exercise program (Arthritis Foundation Aquatics Program). Two classes per week, 45-60 minutes in duration. | Behavioral: Aquatic exercise<br>* Arthritis Foundation Aquatics Program community-based aquatic exercise program participants asked to attend 2 classes per week for 20 weeks each class 45-60 minutes in duration<br>|
| No Intervention: 2<br>Usual care; abstention from initiation of new exercise programs. Invited to participate in Arthritis Foundation Aquatics Program after study completion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Well-Being Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

Detailed Description
-----------------
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

Official Title
-----------------
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Electrocautery
* Procedure: Scalpel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 60 years Scheduled to undergo open carpal tunnel release (OCTR) by a study group member Gives informed consent diagnosis of chronic carpal tunnel syndrome Exclusion Criteria: -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease) History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease) Chronic skin condition in the affected upper limb (e.g. psoriasis) Pregnancy Inability to comprehend the consent form (in Finnish) or inability to give consent Previous surgery or scar in the palmar aspect of the affected wrist Recurrent carpal tunnel syndrome Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scalpel<br>Skin incision performed by scalpel | Procedure: Scalpel<br>* Skin incision performed by scalpel<br>|
| Experimental: Electrocautery<br>Skin incision performed by electrocautery | Procedure: Electrocautery<br>* Skin incision performed by electrocautery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on visual analogue scale |  | First postoperative day |
Nurse-or Surgeon-led Follow-up After Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. The aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.

Official Title
-----------------
Nurse-or Surgeon-led Follow-up After Rectal Cancer: a Randomised Trial.

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Other: Comparison of follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients curatively operated for rectal cancer. Patients had to be more than 18 years of age and written and oral informed consent was obtained. Exclusion Criteria: Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Follow-up<br>Patients curatively operated for rectal cancer | Other: Comparison of follow-up<br>* Comparison of follow-up by nurse or surgeon after rectal cancer surgery<br>* Other names: Rectal cancer patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | At each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource utilisation |  | at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, follow-up, specialist nurse
Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.

Official Title
-----------------
An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Conditions
-----------------
Acne

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered in I-Pledge and has not started the Isotretinoin medication Females and males ages 12-21 years old Able to undergo 3 MRI scan Exclusion Criteria: Participants taking additional vitamin A, D or Calcium supplements Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc) Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease relocation within the next 6 months participation on a research study involving drug medication within the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Skeletal Toxicities Related to the Use of Isotretinoin | Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy | Baseline to 5 months post therapy |
Treatment of a Single Patient With CRD-TMH-001

Study Overview
=================
Brief Summary
-----------------
The study is a single patient study intended to understand the effects of a gene-editing therapeutic to treat a rare mutation of Duchenne muscular dystrophy.

Detailed Description
-----------------
The objective of the study is to assess the safety and preliminary efficacy of CRD-TMH-001 after intravenous administration for a period of 1 year with long-term follow-up out to 15 years.

Official Title
-----------------
Treatment of a Single Patient With CRD-TMH-001

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: CRD-TMH-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of informed consent Confirmation of genetic mutation Confirmation of absence of elevated AAV9 NAbs Exclusion Criteria: - Any significant medical issue(s) (past or current) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

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

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: Single patient<br>Single dose of CRD-TMH-001 administered by IV | Drug: CRD-TMH-001<br>* Participant will receive a single dose of CRD-TMH-001 administered via intravenous injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of CRD-TMH-001 | To assess the safety and tolerability of the therapeutic by measuring both serious and non-serious adverse events. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne, Muscular Dystrophy, CRISPR, gene-editing
Cancer Genome Analysis

Study Overview
=================
Brief Summary
-----------------
Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.

Official Title
-----------------
Cancer Genome Analysis

Conditions
-----------------
Malignant Tumor

Intervention / Treatment
-----------------
* Other: next generation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent

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 |
| --- | --- |
| fresh frozen tumor tissue<br>patients providing fresh frozen tumor tissue | Other: next generation sequencing<br>* next generation sequencing (including targeted gene sequencing, exome sequencing, transcriptome sequenicing)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| targeted sequencing of cancer-relate genes | Identification and characterization of genetic alteration in cancer tissue | 1 year |