linjc16/ctgov huggingface dataset:
Effects of Distraction on Pain and Distress During Venepuncture in Children

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.

Official Title
-----------------
Effects of Distraction on Pain and Distress During Venepuncture in Children

Conditions
-----------------
Pain, Hospitalism in Children

Intervention / Treatment
-----------------
* Other: play computer game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5-7 years old understanding numeral Exclusion Criteria: mental retard and can not nuderstand numeral

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: distraction<br>use the computer game to distract children's pain and anxiety during venepuncture | Other: play computer game<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue pain Scale will be used to evaluate children's pain perception | monitor the children's oxygen saturation and pain scale. | approximately 15 mins during venepuncture process | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venepuncture, distraction, distress
Validation of a Sensor for Non-Invasive Measurements

Study Overview
=================
Brief Summary
-----------------
Subjects will be measured with both a sensor and a reference device

Detailed Description
-----------------
Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.

Official Title
-----------------
Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms

Conditions
-----------------
CHF, Renal Disease, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 (eighteen) years of age at screening. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study. Subject selection will not be based on age, height, or weight. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study. Exclusion Criteria: Subject is participating in another clinical study that may affect the results of either study. Subjects that are pregnant will not be included in the study. Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours. Subject is considered by the Principal Investigator to be medically unsuitable for study participation.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Men/Women who meet the inclusion/exclusion criteria of this protocol. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. | Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. Specifically, Systolic Blood Pressure and Diastolic Blood Pressure with units of millimeters of mercury (mmHg) will be compared. | 3-36 Months | 
| Fluids | Observation of fluid measurement from Sensor (ohms) | 3-36 Months | 
| Heart Rate | Observation of heart rate measurement from Sensor (beats/min) | 3-36 Months | 
| Heart Rate Variability | Observation of heart rate variability from Sensor (milliseconds) | 3-36 Months | 
| Respiration Rate | Observation of respiration rate from Sensor (breaths/min) | 3-36 Months |
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Study Overview
=================
Brief Summary
-----------------
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

Official Title
-----------------
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Conditions
-----------------
Pancreatic Neoplasms, Metastases, Neoplasm

Intervention / Treatment
-----------------
* Drug: GEMZAR
* Drug: ALIMTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body. You must have one tumor that can be physically measured or scanned by the doctor. You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU. You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis. Exclusion Criteria: Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study. Documentation that the cancer has spread to your brain. Pregnant or breastfeeding. A second primary cancer. Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GEMZAR|nan|
|Drug: ALIMTA|nan|

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
-----------------
Pancreas, Cancer, Unresectable or Metastatic Cancer of the Pancreas, Alimta
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.

Official Title
-----------------
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed chronic heart failure Patients treated for at least 6 months with candesartan cilexetil Signed Informed consent Exclusion Criteria: Hypersensitivity to candesartan cilexetil Pregnancy / lactation Severe hepatic impairment

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>Cardiologist´s office patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical signs and symptoms of chronic heart failure (in terms of NYHA status, fluid retention and tiredness/fatigue) after at least 6 months of treatment with candesartan cilexetil |  | 1 visit (after at least 6 months of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil |  | 1 visit (after at least 6 months of treatment) | 
| To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia |  | 1 visit (after at least 6 months of treatment) | 
| To evaluate patient's compliance with prescribed treatment |  | 1 visit (after at least 6 months of treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic heart failure, candesartan cilexetil, clinical signs, symptoms
Fluorouracil Filtering Surgery Study (FFSS)

Study Overview
=================
Brief Summary
-----------------
To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.

Detailed Description
-----------------
Filtering surgery adequately lowers intraocular pressure in most glaucoma patients. However, the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes following unsuccessful filtering operations. Failure of filtering surgery is usually attributed to the proliferation of fibroblasts at the filtering site. The use of 5-FU, an antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture, and in preliminary studies it has increased the success of filtering surgery in a nonhuman primate model. The Fluorouracil Filtering Surgery Study (FFSS) was a randomized, controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-FU treatment. Another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-FU injections. Detailed preoperative and postoperative examinations of the cornea, lens, and retina were performed. Systemic toxicity was assessed by preoperative and postoperative hematologic studies. After the investigators performed the filtering surgery and determined that the new outlet channel was working, patients were randomized to receive either 5-FU injections or standard postsurgical care without 5-FU. The patients treated with 5-FU received subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14. There were 213 patients recruited into the study, 162 with previous cataract extraction and 51 with previous filtering surgery. All patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively. Possible concomitant risks of 5-FU treatment, such as toxic effects to the cornea, lens, or retina, were monitored.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: 5-Fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women with uncontrolled intraocular pressure greater than 21 mm Hg in one or both eyes despite maximal tolerated therapy and who were aphakic or had undergone previous filtering surgery were eligible to participate.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5-Fluorouracil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Development of Human Laboratory Study Model of Cocaine Relapse Prevention. - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the development of human laboratory study model of cocaine relapse prevention.

Detailed Description
-----------------
The primary objective of this study will be to develop experimental procedures and parameters demonstrating arousal and craving responses to cocaine-related environmental cues as a model for future testing of the relapse prevention medication treatment of cocaine addiction.

Official Title
-----------------
Development of Human Laboratory Study Model of Cocaine Relapse Prevention

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Procedure: Cocaine (IV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cocaine dependent, non treatment seeking individuals Exclusion Criteria: Please contact site directly for details.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cocaine (IV)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine craving |  |  | 
| Cocaine related high |  |  |
GlucoClear ICU Study

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.

Detailed Description
-----------------
Design: Non-randomized, non-treatment, prospective, open label Study. The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System. After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours. Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period. After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.

Official Title
-----------------
An ICU Study of Safety and Accuracy Using the GlucoClear CGM System

Conditions
-----------------
Intensive Care Unit Blood Glucose Monitoring

Intervention / Treatment
-----------------
* Device: GlucoClear System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent Exclusion Criteria: Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GlucoClear System<br> | Device: GlucoClear System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15/20% Accuracy | 15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values < 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL) | During 72 hours of anticipated Sensor dwell time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12/15% Trend Accuracy | 12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is < 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL). | During 72 hours of anticipated Sensor dwell time. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose monitoring, Intensive care unit
UV and Bluelight Dosimetry

Study Overview
=================
Brief Summary
-----------------
The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.

Official Title
-----------------
Pilot Studies of UV-A, UV-B, and Blue-light Dosimetry Sensors

Conditions
-----------------
Environmental Exposure

Intervention / Treatment
-----------------
* Device: Wearable Ultra Violet (UV) and blue-light sensors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Subjects willing and able to comply with requirements of the protocol Subjects speaking English Exclusion Criteria: Age <18 years old Subjects unwilling and unable to comply with requirements of the protocol History of skin allergy to medical adhesive tape or rubber bands/elastic Lack of proficiency in English Skin disorders affecting skin integrity

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

| Intervention/Treatment |
| --- |
|Device: Wearable Ultra Violet (UV) and blue-light sensors|Non-blinded|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings. | After sensors are removed researchers will collect dosimetry data using a phone application using Near Field Communication (NFC) with a phone that is restricted to research use only in this study. Location, indoor/outdoor conditions and time that the devices are used will be recorded by the study team. Location, external environmental factors (weather, UV index) and activities will be recorded by the research administrators. | Time Frame: 1 year |
Evaluation of Total Disability (I.T.T.) in Victims of Psychotraumatism.

Study Overview
=================
Brief Summary
-----------------
The increase in psychological violence in our society, but also and above all the search for the best possible reparation for this violence, leads increasingly to questioning the evaluation of psychotraumatisms. In practice, there is no consensus as to the method of assessing psychological repercussions and determining ITI. This topic concerns any physician

Detailed Description
-----------------
The increase in psychological violence in our society (psychological repercussions of physical violence, situations of harassment, psychotraumatism linked to the series of attacks suffered in France), but also and above all, the search for the best possible reparation for this violence The victims and the society), leads increasingly to question the evaluation of psychotraumatisms. In practice, there is no consensus as to the method of assessing psychological repercussions and determining ITI. This topic concerns any physician involved in the care of victims, whether he is a doctor in primary care or in specialized care.

Official Title
-----------------
Evaluation of the Total Incapacity of Work (I.T.T.) in the Victims of Psychotraumatism Taken Care of in the Medico-judicial Unit of the CHU of Montpellier by Forensic Doctors and Psychologists

Conditions
-----------------
Psychotraumatism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients over 18 years of age taken in charge at the Médico-Judiciaire Unit of the CHU Montpellier following a physical and / or psychological traumatism. - - Starting up between 01.01.2016 and 31.12.2016. Patients who have undergone a double assessment (medical and psychological). Exclusion criteria: Patients under the age of 18 years. Consultation within the framework of a takeover started before 01.01.2016. Absence of double medical and psychological evaluation.

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 |
| --- | --- | --- |
| Medico-psychological interviews | Study of standardized questionnaires resulting from medico-psychological interviews, the data of which will have been gathered during consultations as part of the care | 1 day |