linjc16/ctgov huggingface dataset:
Screening Cardiovascular Patients for Aortic Aneurysms

Study Overview
=================
Brief Summary
-----------------
Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness of screening for AAA in men in the Netherlands has been demonstrated by using a Markov model. Screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an AAA. Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. This pilot project aims to study the value of a screening protocol in daily practice to detect AAA's in high risk patients.

Detailed Description
-----------------
Offering PAD and CAD patients a non-invasive abdominal ultrasound after a careful process of shared-decision making Recording data on aneurysm detection on all PAD and CAD patients screened: General information (age, gender) Medical history on CardioVascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart) AAA - Yes/ No (Yes if ≥3 cm AAA) If ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment) If treated, record treatment type (EVAR or Open) and outcome

Official Title
-----------------
Screening Cardiovascular Patients for Aortic Aneurysms

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients peripheral arterial disease (ankle brachial index < 0,90 and/or reduction of > 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%) age > 55 year Exclusion Criteria: Patients unfit for endovascular or open surgery (as judged by vascular surgeon) Failure to master the dutch language

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| AAA prevalence |  | 1 year |
Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Study Overview
=================
Brief Summary
-----------------
Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Detailed Description
-----------------
Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Official Title
-----------------
Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Conditions
-----------------
Aplastic Anemia and Other Marrow Failure Syndrome

Intervention / Treatment
-----------------
* Other: Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed Aplastic Anemia and Other Marrow Failure Syndrome Database. Exclusion Criteria: Patients with diagnosis other than Aplastic Anemia and Other Marrow Failure Syndrome Database.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Database|Database|

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
-----------------
Aplastic Anemia Marrow Failure Syndrome
Shared Decision Making for Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.

Detailed Description
-----------------
to follow

Official Title
-----------------
Shared Decision Making in the Therapy of Schizophrenia

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

Intervention / Treatment
-----------------
* Behavioral: Decision aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia (ICD10) age 18 - 65 years inpatients Exclusion Criteria: mental retardation no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

| Intervention/Treatment |
| --- |
|Behavioral: Decision aid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' compliance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived involvement in medical decisions |  |  | 
| rehospitalizations |  |  | 
| QoL |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, shared decision making, compliance, maintenance therapy
Maternal Uterine Artery Doppler Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.

Detailed Description
-----------------
In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta. Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment modality has met with only limited success. Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance. If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta.

Official Title
-----------------
A Simple Technique to Modify Maternal Uterine Artery Perfusion.

Conditions
-----------------
Maternal-Fetal Exchange

Intervention / Treatment
-----------------
* Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women greater than or equal to 18 years old Able to speak and read English Have a singleton pregnancy greater than or equal to 18 weeks gestation Exclusion Criteria: Multiple gestation Less than 18 weeks gestation Uterine anomalies Fetal anomalies Preeclampsia Hypertension Inability to have BP cuff on left arm

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UA Doppler Velocimetry<br>Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly. | Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.<br>* bilateral Uterine artery Doppler readings pre- and during blood pressure measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Artery Doppler | The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby. | at time of routine ultrasound | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnant women, Uterine Artery Doppler Velocimetry
Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to check whether patients with cystoscopic findings supporting the diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood pressure / pulse)than patients without cystoscopic findings.

Detailed Description
-----------------
checking the changes in blood pressure and pulse rate during the initiation of the anesthesia and at the completion of the cystodistension in patient with cystoscopic finding supporting IC

Official Title
-----------------
Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

Conditions
-----------------
Interstitial Cystitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients having cystodistension suspected of painful bladder syndrome symptoms lasting for at least six months symptoms suspect of the syndrome: super pubic pain, urinary urgency and frequency lack of urinary infection or any other pathology of the urinary tract Exclusion Criteria: Refusal of the patient to participate

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 |
| --- | --- | --- |
| changes in blood pressure and pulse |  | measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomic response
Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic neuropathy Exclusion Criteria: Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the efficacy of 200, 400, and 600mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, and quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide. |  |  |
Pulmonary Hypertension in Trisomy 21 Patients

Study Overview
=================
Brief Summary
-----------------
Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect. Life-threatening pulmonary hypertensive crises may occur in these patients when they no longer have an atrial communication to decompress high right heart pressures. This concern has led some to advocate fenestrated patch closure of ASDs in patients with pulmonary hypertension with the prospect of a repeated procedure in order to close the fenestrations at a later date.

Detailed Description
-----------------
Pre-operative resolution of pulmonary hypertension would clearly provide the best long-term outcome for these patients, allowing a definitive surgical procedure. There are no reported cases of resolution of pulmonary hypertension with the use of pulmonary vasodilators allowing successful ASD closure. We report the case of a patient with trisomy 21 and a primum atrial septum defect with associated cleft mitral valve who was diagnosed with pulmonary hypertension at 8 days of life. Elevated pulmonary pressures were documented by cardiac catheterization during which the patient was found to have minimally responsive pulmonary vasculature to the administration of oxygen. He was started on pulmonary vasodilators which were continued for the following 5 months which resulted in gradual reduction in estimated PA pressure allowing successful closure of the primum ASD and repair of the cleft mitral valve. Following surgery, he was not restarted on pulmonary vasodilators and has continued to do well. The ability to reverse his pulmonary hypertension through the use of pulmonary vasodilators made him a candidate for his successful, definitive surgical repair. He currently has no residual cardiac problems and requires no cardiac medications. There will be no patient follow-up.

Official Title
-----------------
Case Report: Resolution of Pulmonary Hypertension With Sildenafil and Bosentan in Patients With Trisomy 21 and Atrial Septal Defect

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case report of a patient with trisomy 21 and primum atrial septum defect with associated cleft mitral valve who was diagnosed with pulmonary hypertension at 8 days of life Exclusion Criteria: those who do not fit into inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 8 Days

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
-----------------
Pulmonary hypertension, Sildenafil, Bosentan, Trisomy 21, Atrial septal defect
Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Malnutrition is seen frequently in hemodialysis units in most developing countries. Malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status The purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis. This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment (SGA) in addition to most used biochemical markers to determine nutritional status.

Official Title
-----------------
Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients

Conditions
-----------------
Protein-Energy Malnutrition, Kidney Failure, Chronic, Hemodialysis

Intervention / Treatment
-----------------
* Dietary Supplement: Egg albumin-based protein supplement
* Dietary Supplement: Renal-specific oral supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Kidney Disease in Hemodialysis Exclusion Criteria: Infection Liver insufficiency Cancer or neoplasia Acquired immunodeficiency syndrome Intestinal malabsorption syndrome

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg albumin-based protein supplement<br>Powder form, dosage 30 g daily, duration 6 months | Dietary Supplement: Egg albumin-based protein supplement<br> <br> * Other names: Pure ProEgg;|
| Active Comparator: Renal-specific oral supplement<br>Liquid form, dosage 237 ml (one can) daily, duration 6 months | Dietary Supplement: Renal-specific oral supplement<br> <br> * Other names: Enterex Renal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Malnutrition-Inflammation Score |  | Bimonthly, up to six months | 
| Change in Subjective Global Assessment |  | Bimonthly, up to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Protein-Energy Malnutrition, Chronic Kidney Disease, Malnutrition-Inflammation Score, Subjective Global Assessment, Hemodialysis, Egg albumin
PREG-MS: New England MS Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate. The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study. Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.

Official Title
-----------------
PREG-MS: New England MS Pregnancy Prospective Cohort Study

Conditions
-----------------
Multiple Sclerosis, Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Multiple Sclerosis; Pregnant or actively planning to become pregnant. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| The relationship between EDSS and pregnancy course | The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between MS treatments and pregnancy course | The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course. | 9 months |