linjc16/ctgov huggingface dataset:
Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
Iron deficiency anemia is a worldwide medical disorder. So far, it is the most common medical complication in pregnancy specially in developing countries. It is the cause of many adverse effects on mother and fetus and contributes significantly to high maternal mortality. Maternal iron deficiency anemia is frequently associated with premature delivery, low birth weight babies

Official Title
-----------------
Fetal Vascular Hemodynamic Changes Before and After Treatment of Maternal Iron Deficiency Anemia

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Iron Sucrose Solution for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with gestational age 28-32 weeks singleton pregnancy iron deficiency anemia. Exclusion Criteria: Multiple pregnancy antepartum hemorrhage major congenital fetal anomalies any other type of anemia other than iron deficiency anemia any acute or chronic maternal disease other than iron deficiency anemia.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>patients with iron deficiency anemia | Drug: Iron Sucrose Solution for Injection<br>* intravenous infusion of iron sucrose<br>|
| control group<br>normal pregnant patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean changes in middle cerebral artery Doppler of the fetus | Doppler evaluation | one month |
Longitudinal Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).

Detailed Description
-----------------
The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads). The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include: I. To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes

Official Title
-----------------
Longitudinal Surveillance Registry

Conditions
-----------------
Heart Failure, Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician) Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR Exclusion Criteria: Patient who cannot be followed on the LATITUDE Patient Management system Patient who is unable or unwilling to comply with the protocol requirements
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, CRT-D
Registry of Mastectomy for Breast Cancer Risk Reduction

Study Overview
=================
Brief Summary
-----------------
This is a registry for patients who have a risk-reduction mastectomy (prophylactic mastectomy) due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.

Official Title
-----------------
Registry of Mastectomy for Breast Cancer Risk Reduction

Conditions
-----------------
Genetic Predisposition to Disease, Adjustment Disorder, Quality of Life, Mastectomy, Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at an elevated risk for breast cancer. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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>Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up. |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following. |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective study, registry, quality of life, mastectomy, reconstructive surgical procedures, BrCa1, BrCa2, breast cancer prevention
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively. Effect on the hormones and the immune system is evaluated using blood samples.

Detailed Description
-----------------
To investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively using forearm flow mediated dilatation. Effect on the blood natriuretic peptides and the inflammatory markers is evaluated using blood samples at baseline and after the training or control period.

Official Title
-----------------
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients

Conditions
-----------------
Heart Transplantation, Exercise Capacity, Endothelial Function

Intervention / Treatment
-----------------
* Other: Intensive physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplant recipients > 1 year after transplantation Exclusion Criteria: Recent rejection, severe renal dysfunction, graft dysfunction, allograft vasculopathy, cancer, inability to exercise.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Other: Intensive physical exercise<br>* Intensive physical exercise 1 hour three times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal oxygen uptake. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change inm flow mediated vasodilatation. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart transplantation, Exercise capacity, Endothelial function
Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.

Official Title
-----------------
Lack of Acute Tolerance Development to Effects of Nitrous Oxide

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 0% N2O
* Drug: 10% N2O
* Drug: 20% N2O
* Drug: 30% N2O
* Drug: 40% N2O


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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 29 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 0% N2O<br>Subjects will inhale 0% N2O | Drug: 0% N2O<br> <br> |
| Active Comparator: 10% N2O<br>Subjects will inhale 10% N2O | Drug: 10% N2O<br> <br> |
| Active Comparator: 20% N2O<br>Subjects will inhale 20% N2O | Drug: 20% N2O<br> <br> |
| Active Comparator: 30% N2O<br>Subjects will inhale 30% N2O | Drug: 30% N2O<br> <br> |
| Active Comparator: 40% N2O<br>Subjects will inhale 40% N2O | Drug: 40% N2O<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor performance | Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention | During inhalation | 
| Cognitive performance | Subjects will under cognitive testing during 120 minute inhalation session of each intervention | During inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychomotor, nitrous oxide, acute tolerance, subjective effects, analgesia, healthy volunteer
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters

Study Overview
=================
Brief Summary
-----------------
This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique.

Official Title
-----------------
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters

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

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.2%
* Drug: Ropivacaine 0.75%
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically established carpel tunnel syndrome Surgery performed under local anesthesia Exclusion Criteria: Chronic pain requiring analgesics

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br> | Drug: Ropivacaine 0.2%<br>* 10 ml<br>|
| Active Comparator: Group B<br> | Drug: Ropivacaine 0.75%<br>* 3 ml<br>|
| Placebo Comparator: Group C<br> | Drug: Normal saline<br>* 10 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique. |  | Up to 1 yr after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthetics, Local, ropivacaine, Surgery, Hand, carpel tunnel, Carpal tunnel surgery
CMR Repeatability in STEMI

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.

Official Title
-----------------
Cardiovascular Magnetic Resonance Scan Repeatability in ST Segment Elevation Myocardial Infarction

Conditions
-----------------
STEMI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant may enter study if ALL of the following apply ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with >1 mm ST-segment elevation, or >2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and > 20 minutes of cardiac chest pain Written informed consent Exclusion Criteria: Participant may not enter study if ANY of the following apply Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner) Known allergy to gadolinium Chronic atrial fibrillation Renal impairment with eGFR <30 Cardiogenic shock Patients with special communication needs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer, intra-observer and inter-scan variability and agreement |  | Between 2 scans |
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Study Overview
=================
Brief Summary
-----------------
Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions. Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.

Official Title
-----------------
Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Conditions
-----------------
Gastric Dysplasia, Intestinal Metaplasia

Intervention / Treatment
-----------------
* Device: Endoscopic radiofrequency ablation catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of gastric IM or dysplasia. The lesion is no larger than 5 cm in diameter. Age ≥ 18 years. No previous endoscopic mucosal resection or submucosal dissection. No active H. pylori infection. Subject is able to tolerate endoscopy and sedation. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form. Exclusion Criteria: Gastric cancer (intra-mucosal cancer or worse). Prior gastric irradiation or surgery. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA. Gastric ulcers, fistulae and varices. History of alcohol and/or controlled substance dependency. Pregnancy.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic radiofrequency ablation<br>Endoscopic radiofrequency ablation using BARRX HALO90 catheter | Device: Endoscopic radiofrequency ablation catheter<br>* Endoscopic radiofrequency ablation<br>* Other names: BARRX HALO90;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological clearance of dysplasia/metaplasia |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | up to 6 month |
iSTAT Comparison Study, IRB3785

Study Overview
=================
Brief Summary
-----------------
Pleural fluid glucose levels measured with bed-side point of care methods such as finger stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.

Detailed Description
-----------------
This is a prospective study which will identify patients in VAMC with a diagnosis of pleural effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick glucometer) to measure pleural fluid glucose levels. The results obtained from these two methods will be compared to the traditionally in lab measured pleural fluid glucose levels.

Official Title
-----------------
Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).

Conditions
-----------------
Pleural Effusions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis. Exclusion Criteria: Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| iSTAT Study Group<br>Measure glucose of pleural fluid via glucometer, in the laboratory, and using the iSTAT device to see if the three methods give a similar reading or not. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab | Primary outcome will be the inter-assay precision of the finger stick glucometer and the I-STAT device as compared to the Gold standard in lab testing of pleural glucose.This will be done using the Bland-Altman plot. | <1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device. | assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device . | < 1hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pleural, glucose, glucometer, i-STAT