linjc16/ctgov huggingface dataset:
Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Study Overview
=================
Brief Summary
-----------------
Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low. Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program. Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly during a surveillance program. Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of GIST size. Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.

Official Title
-----------------
Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Conditions
-----------------
Gastrointestinal Stromal Cell Tumors, Foregut Subepithelial Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting for EUS with an indication for a SEL in the stomach or esophagus at least 18 years of age able to provide informed consent Exclusion Criteria: no subepithelial lesion in the stomach or esophagus' less than 18 years of age unable to provide 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 |
| --- | --- |
| Observation Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the degree of patient compliance with surveillance recommendations. |  | 3 years | 
| Describe the diagnostic yield of EUS±FNA in evaluating SELs. |  | 2 weeks | 
| Compare SEL size estimation based on EUS, EGD and computer tomography (CT). |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, endoscopy, endoscopic ultrasound
Iron Deficiency Anemia in Childern With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients

Detailed Description
-----------------
Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .

Official Title
-----------------
Prevelance of Iron Deficiency Anemia in Liver Cirrhosis in Childern

Conditions
-----------------
Iron Deficiency, Anaemia in Children, Liver Cirrhosis

Intervention / Treatment
-----------------
* Diagnostic Test: transferrin receptor concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all childern with liver cirrhosis in GIT and hepatology unit Exclusion Criteria: Neonates less than one month childern with other liver diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: transferrin receptor concentration<br>Prevelance of iron deficiency in this patients | Diagnostic Test: transferrin receptor concentration<br>* Sandwich radio-imunoassay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevelance of IDA in liver cirrhosis | To evaluate results | two years |
Testing Latest Version of NidekRS3000Adv

Study Overview
=================
Brief Summary
-----------------
The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.

Official Title
-----------------
Testing Latest Version of NidekRS3000Adv

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

Intervention / Treatment
-----------------
* Device: RS3000Adv


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants 18 years old or older Exclusion Criteria: Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging subjects who are unable to maintain retinal fixation on a specified target subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place subjects with media opacity which preclude high quality imaging will be excluded. vulnerable subjects subjects under 18 pregnant subjects economically and educationally disadvantaged subjects decision impaired subjects homeless subjects

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: RS3000Adv|Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular vascularization | Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants | 1 year |
Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

Study Overview
=================
Brief Summary
-----------------
Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.

Official Title
-----------------
Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: 24 h urines analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization for a cardiovascular check in the Detection Centre and the Atherosclerosis Prevention (CHU Rangueil Toulouse) In primary prevention of coronary heart disease Introducing an intermediate cardiovascular risk according to the European SCORE equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5% signed the informed consent, Exclusion Criteria: Chronic renal failure patients with an estimated GFR less than 60 mL / min / 1.73m2, due to alterations in phosphate metabolism, Patients receiving glucose-lowering therapy, Patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l. The diuretic therapy patients (due to a change in urinary electrolytes) HIV-positive patients for HIV, antiretroviral (due to a change in urinary electrolytes) Pregnant women, Patients under judicial protection, guardianship or trusteeship.

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 |
| --- | --- |
| patient<br>patient with cardiovascular risk (moderate) | Other: 24 h urines analyses<br>* patient collects urines during 24h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma levels of FGF23 according to the calcium score, determined by an ELISA method |  | 1 day |
Parkdale Infant Nutrition Security Targeted Evaluation Project: Chart Review

Study Overview
=================
Brief Summary
-----------------
In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada. It is important to know who is accessing community programs and what the drivers of program utilization are in order to better support the women who are enrolled and to target those who are not. The aim of this project is twofold: 1) to investigate what socio-demographic and psychosocial characteristics predict level of participation in a prenatal community outreach program targeting vulnerable mothers and 2) based on utilization of a prenatal program, are there differences in the use of a postnatal program? This study will be conducted through a retrospective chart review. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that more vulnerable women will not attend programming as frequently.

Official Title
-----------------
Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 1-Retrospective Chart Review)

Conditions
-----------------
Prenatal Community Program, Vulnerable Population, Postnatal Community Program

Intervention / Treatment
-----------------
* Other: Chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally 5P's client signed the permission to release information on the 5P's intake form Exclusion Criteria: Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally 5P's client did not sign the permission to release information on the 5P's intake form
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Program Clients<br>Parkdale Parents' Primary Prevention Project (5P's) clients | Other: Chart review<br>* Retrospective chart review of program participation and socio-demographic & psychosocial characteristics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of program participation as assessed by review of client records and program attendance records | Retrospective chart review of client program records and attendance | Registration to prenatal program until 12 months postpartum |
Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic

Study Overview
=================
Brief Summary
-----------------
PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.

Official Title
-----------------
Thai Red Cross AIDS Research Centre (TRC-ARC)

Conditions
-----------------
HIV Prevention

Intervention / Treatment
-----------------
* Drug: PrEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years HIV test negative Creatinine clearance > 60 ml/min No contraindication or allergy to PrEP medications (TDF/FTC) At least one risk factor for HIV infection within the previous 6 months: sex partner known to be HIV positive works as commercial sex worker use of PEP for sexual exposure injection drug use any STI (syphilis, gonorrhea, chlamydia) > 5 sex partners inconsistent condom use with high-risk partners, including MSM, IDU MSM: any insertive or receptive anal sex without condom Women: any sex without condom with high-risk male partner (MSM, IDU, multiple female partners) Heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, IDU, multiple male partners) Exclusion Criteria: -

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 |
| --- |
|Drug: PrEP|Oral pre-exposure prophylaxis (PrEP) for HIV infection using a daily combination tablet of tenofovir disoproxil fumarate and emtricitabine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures: | Assess the uptake of fee-based oral PrEP by MSM and other at-risk individuals who present for HIV testing or other services. Assess the acceptability, tolerance and safety of oral PrEP. Assess patient satisfaction with oral PrEP delivered through a fee-based system in an HIV testing center. Assess the effectiveness of oral PrEP in a fee-based model. Assess the cost-effectiveness of oral PreP delivered in a fee-based system. | 12 months |
SOMNOmedics Clinical Validation Trial

Study Overview
=================
Brief Summary
-----------------
Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure. The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

Detailed Description
-----------------
Plan to enroll patients who accept the terms of the study consecutively. The population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring. After informed consent from the patients themselves, patient and parents and sometimes only parents. The device measuring PTT is the prepared and calibrated with existing arterial blood pressure. Data is then recorded via the storage capacity of the device and via videocamera. The videocamera is used to identify large disturbances in data registration. This is to identify confounding data and in the end calibrate the device to be more accurate. Data from the PTT device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage. Data is then analysed to compare the difference between data recorded from the PTT device and arterial pressure respectively. Aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use. Patient data is registered and then handled by our departmental clerk. Data is stored for ten years.

Official Title
-----------------
SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.

Conditions
-----------------
Blood Pressure, Perioperative/Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arterial line planned or existing Exclusion Criteria: suspected major perioperative hemodynamic variation. non existing consent.
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement. | Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements, | 45 minutes- 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perioperative monitoring
The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.

Detailed Description
-----------------
The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery

Official Title
-----------------
Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery

Conditions
-----------------
Postoperative Pain, Shoulder Surgery

Intervention / Treatment
-----------------
* Drug: Naropin 0.1% cum sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Age 18-80 Shoulder surgery performed under interscalene block and general anesthesia Exclusion Criteria: Contraindication of interscalene block Severe chronic obstructive lung disease Non-cooperative patient Intolerance to opioids Pregnancy Rheumatoid arthritis and diabetes with peripheral polyneuropathy Chronic pain or daily opioid intake

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naropin 0.1%<br> | Drug: Naropin 0.1% cum sufentanil<br>* 20ml of Naropin 0.1% cum sufentanil 1mikrog per ml<br>* Other names: Ropivacain;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to experience of moderate to severe postoperative pain |  | On day of surgery and 1., 2. and 3. postop. day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | On day of surgery and 1., 2. and. 3. postop. day |
DiGESTnewborn Study

Study Overview
=================
Brief Summary
-----------------
We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.

Official Title
-----------------
Glucose Control and Metabolic Adaptation in Offspring of Women With Gestational Diabetes Recruited to the DiGest Study

Conditions
-----------------
GDM, Hypoglycemia

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|This is a cohort study no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal sensor glucose time in target | Time sensor glucose levels in target in the first week of life | From sensor insertion for up to the first 7 days of life |
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.

Official Title
-----------------
An Open-Label Positron Emission Tomography (PET) Study to Demonstrate Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of ITI-007 in Stable Schizophrenia Patients

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ITI-007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia who are drug-free with regard to their antipsychotic medication In clinical remission and free from acute exacerbation of their psychosis In good health Exclusion Criteria: Clinically significant medical conditions considered inappropriate for trial participation

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITI-007<br>ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects. | Drug: ITI-007<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Receptor Occupancy as Measured by Positron Emission Tomography |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Measured by Number of Participants with Adverse Events |  | Up to 14 days |