linjc16/ctgov huggingface dataset:
TCOM Ring Evaluation

Study Overview
=================
Brief Summary
-----------------
Subjects that are currently on a transcutaneous carbon dioxide monitor (TCOM) to monitor the carbon dioxide level in their blood will be placed on an additional TCOM using a non-adhesive sensor application ring instead of the usual adhesive ring to hold the TCOM sensor in place in order to evaluate usability of the non-adhesive applicator.

Official Title
-----------------
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates

Conditions
-----------------
Carbon Dioxide Partial Pressure Determination, Transcutaneous

Intervention / Treatment
-----------------
* Other: Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature or term birth newborn infants requiring transcutaneous monitoring Thigh circumference of greater than 63mm Weight greater than or equal to 600g Ability of caretaker to understand verbal and written instructions and informed consent Exclusion Criteria: Absence of written informed consent. Skin condition contraindicating transcutaneous measurements. Thigh circumference less than or equal to 63 mm

Ages Eligible for Study
-----------------
Minimum Age: 5 Minutes
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluation|Evaluation of ease of use|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates |  | 3 Months |
GIP and GLP-1 in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Other: GIP
* Other: GLP-1
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Diagnosed with type 1 diabetes (WHO criteria) Exclusion Criteria: HbA1c > 9 % Liver disease (ALAT/ASAT > 2 x upper normal limit) Diabetic nephropathy (s-creatinine > 130 µM or albuminuria) Proliferative diabetic retinopathy (anamnestic) Severe arteriosclerosis or heart failure (NYHA group III or IV) Anemia treatment with medication not applicable to pause for 12 hours C-peptide increase after 50 g iv arginine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperglycemia<br>Hyperglycemic clamping | Other: GIP<br> <br> Other: Saline<br> <br> |
| Experimental: hypoglycemia<br>Hypoglycemic clamping | Other: GIP<br> <br> Other: GLP-1<br> <br> Other: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucagon area under curve values |  | approx. 15 minutes intervals, time 0 to 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma gut hormones and nutrients (absolute, incremental and area under curve values) |  | approx. 15 minutes intervals, time 0 to 120 min |
Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Detailed Description
-----------------
Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which may be upregulated when there are stimuli such as inflammation or hypergastrinaemia. Despite radical surgery, patients with stomach cancer of advanced stages often have a poor prognosis. Reported survival in those with diseases of stage IIIa or above is less than 40%. Methods to improve patients outcome have been explored for decades with little success. In the light of current understanding on the relation between COX-II and stomach cancer, selective COX-II inhibitor may be used as a novel adjuvant therapy after gastrectomy to prevent recurrence of gastric carcinoma. The advantages of COX-II inhibitors are being relatively non-toxic with minimal side effect.

Official Title
-----------------
Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

Conditions
-----------------
Cancer of Stomach

Intervention / Treatment
-----------------
* Drug: Oral Vioxx (Rofecoxib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases. Normal renal function Exclusion Criteria: Solid organ metastases Poor performance status Already on long-term aspirin or NSAID Renal or hepatic dysfunction Bleeding disorder Hypersensitive to COX-II inhibitors/aspirin/NSAID No history of myocardial infarct or stoke

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral Vioxx (Rofecoxib)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival and the quality of life score within the two years of study period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in long term |  |  |
Investigate Role of Metabolic Imaging in Predicting Tumor Response/Outcome After Pancreatic CA Tx

Study Overview
=================
Brief Summary
-----------------
To test the ability of new imaging techniques to monitor and predict response of pancreatic cancer to radiation and/or chemotherapy.

Official Title
-----------------
Pilot Study to Investigate the Role of Metabolic Imaging in Predicting Tumor Response and Outcome After Therapy for Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: PET Scan
* Drug: FLT
* Drug: FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Adult patients (>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery. Negative urine pregnancy test if a woman of child-bearing potential (WOCBP). WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period. All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility. Exclusion Criteria:1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for >5 years will be allowed to enter the trial. 3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PET Scan|nan|
|Drug: FLT|nan|
|Drug: FDG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the performance of the novel imaging methods |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate FLT activity with clinical outcomes |  |  |
Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation

Study Overview
=================
Brief Summary
-----------------
Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients. Goal: To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Official Title
-----------------
Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy) Patients receiving radiotherapy dose > 40 Gy Exclusion Criteria: Failure to comply with any of the inclusion criteria

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 |
| --- |
|Radiation: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | esophagitis (Common Terminology Criteria for Adverse Events, version 4.0) | Highest during and within 2 weeks after last day of radiation therapy | 
| Late toxicity | esophagitis (Common Terminology Criteria for Adverse Events, version 4.0); pneumonitis (Common Terminology Criteria for Adverse Events, version 4.0) | Highest within one year after last day of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | at 1 year after first day of radiation therapy | 
| Overall survival |  | at 2 years after first day of radiation therapy | 
| Overall survival |  | at 3 years after first day of radiation therapy | 
| Overall survival |  | at 4 years after first day of radiation therapy | 
| Overall survival |  | at 5 years after first day of radiation therapy | 
| Loco-regional tumor control |  | at 1 year after first day of radiation therapy | 
| Loco-regional tumor control |  | at 2 years after first day of radiation therapy | 
| Loco-regional tumor control |  | at 3 years after first day of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute toxicity, Late toxicity, Prediction models
French Survey About Student's Sleep Perturbations Before Simulation Session.

Study Overview
=================
Brief Summary
-----------------
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants. The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.

Detailed Description
-----------------
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants. The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their quantity and quality of sleep affected before the simulation session.

Official Title
-----------------
French National Investigation About Student's Sleep Perturbations Before Simulation Session.

Conditions
-----------------
Sleep, Anxiety

Intervention / Treatment
-----------------
* Other: simulation practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: french talking residents coming to high fidelity simulation Exclusion Criteria: refusal to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: simulation practice|simulation session|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modification of the sleeping Leeds test |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of sleep perturbations |  | day 1 | 
| analysis of demographics and sleep perturbations |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Medical
Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children

Study Overview
=================
Brief Summary
-----------------
Idiopathic purpura fulminans by anti-protein S antibody is a very rare but potentially extremely serious entity. The data in the literature are poor with only isolated report boxes and a single series of less than 10 boxes. The creation of a larger series of cases would make it possible to better understand this pathology and to offer assistance in diagnosis and management.

Official Title
-----------------
Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children: a French Multicenter Retrospective Study

Conditions
-----------------
Idiopathic Purpura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: diagnostic of idiopathic purpura fulminans Acquired protein S deficiency Exclusion criteria: - Other infecious purpura diagnosis

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Rate of anti-protein S antibody | Rate of anti-protein S antibody | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Protein S acquired deficiency, Idiopathic purpura fulminans
Mindfulness Practice for Healthcare Professionals in Training

Study Overview
=================
Brief Summary
-----------------
A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility, acceptability, accessibility, and preliminary effects within this population.

Official Title
-----------------
Mindfulness Practice for Healthcare Professionals in Training

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Practices for Healthcare Professionals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare professional Healthcare professional in training Exclusion Criteria: None

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participant<br> | Behavioral: Mindfulness Practices for Healthcare Professionals<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of participants regarding feasibility and acceptability | open-ended questions (qualitative) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burnout (MBI) | MBI | 8 weeks | 
| Perceived stress (PSS) | PSS | 8 weeks | 
| Depressive symptoms (PHQ9) | PHQ9 | 8 weeks | 
| Mindfulness (FFMQ) | FFMQ | 8 weeks | 
| Anxiety (STAI) | STAI | 8 weeks | 
| Ruminations (RRS) | RRS | 8 weeks |
Characteristics of Episodic Ataxia Syndrome

Study Overview
=================
Brief Summary
-----------------
Episodic ataxia (EA) is a rare genetic disease characterized by episodes of imbalance, incoordination, and slurring of speech. The underlying cause of EA is only partly understood, and currently there are no established treatments. There is also little information about the link between EA's clinical features and its genetic basis. The purpose of this study is to better characterize EA and disease progression. In turn, this may direct the development of future treatments.

Detailed Description
-----------------
Attacks of ataxia, or the loss of ability to coordinate muscular movement, are often triggered by stress or exertion. EA is likely caused by an inherited genetic mutation; many individuals with EA have abnormalities in the KCNA1 or CACNA1A genes. To date, two known subtypes of EA have been identified, and other types likely exist. Specific characteristics of each EA subtype, however, have not been adequately described. The purpose of this study is to better define the clinical features and genetic basis of the various subtypes of EA and to evaluate disease progression. The study will also establish relevant study endpoints for use in future therapeutic trials. This multi-center observational study will involve both a cross-sectional data analysis and a prospective longitudinal analysis. Participants will initially attend an outpatient study visit that will last 7 hours. This initial evaluation will include a medical history, a physical examination, neurological testing, and an ataxia assessment. Blood will be collected for genetic testing. Additionally, the following procedures may be conducted: ocular motor test, electromyography/nerve conduction study, electroencephalogram, MRI, and digital videotaping. Follow-up evaluations will occur on a yearly basis for at least 2 years; each will last 4 hours.

Official Title
-----------------
Episodic Ataxia Syndrome: Genotype-phenotype Correlation and Longitudinal Study

Conditions
-----------------
Episodic Ataxia Syndrome, Cerebellar Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinically confirmed diagnosis of episodic ataxia as defined by one of the following three features: Clear-cut episodes of recurrent, transient ataxia Mutation confirmed in KCNA1 or CACNA1A Ataxic features with a first degree relative with episodic ataxia Exclusion Criteria: Any other disorder known to cause episodic ataxia

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |
Comorbidities of Epilepsy

Study Overview
=================
Brief Summary
-----------------
Epilepsy is the second commonest chronic neurological disorder in developed countries, Comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population

Official Title
-----------------
Comorbidities of Epilepsy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as primary epilepsy either newly diagnosed or on AEDs Aged above 18 years old Males and females Exclusion Criteria: Patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc). Patients diagnosed as epilepsy syndrome

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 |
| --- | --- | --- |
| DEXA Scan | DEXA scan to measure bone mineral density at 3 points (wrist joint ,hip joint and lumbo-sacral vertebrae) | 1 year |