linjc16/ctgov huggingface dataset:
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population. Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture. Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent. 800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.

Official Title
-----------------
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Other: ultrasound of aorta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with coronary artery disease Exclusion Criteria: Already diagnosed or treated abdominal aortic aneurysm Patient's denial to participate Malignant disease

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

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

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

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

Design Details

Primary Purpose: Screening


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ultrasound of aorta<br> | Other: ultrasound of aorta<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound |  | Upon screening (AAA-screening appointment, 10 minutes per patient) |
POWERMOM, A Healthy Pregnancy Research Community

Study Overview
=================
Brief Summary
-----------------
This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.

Detailed Description
-----------------
Eligibility determined, Individuals enrolled and consented to join study Short Intake Survey (demographic and baseline health information collected) Health History Survey (two days after participant enrolls in the study) Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked. Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit. Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly. If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.

Official Title
-----------------
POWERMOM, A Healthy Pregnancy Research Community

Conditions
-----------------
Pregnancy Related, Weight Change, Body, Health Problems in Pregnancy, Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 16 years of age or older Pregnant women or within 8 weeks postpartum Currently live within the United States Own, and comfortable using, a smartphone or tablet Exclusion Criteria: • Inability to consent

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve our understanding of healthy pregnancy weight gain for all women. | Weight (lbs.) will be collected using surveys and measured with home and medical office scales. | Up to 46 weeks. | 
| Improve our understanding of how different factors impact pregnancy complications. | Pregnancy complications will be collected using surveys. | Up to 46 weeks. | 
| Improve our understanding how different factors impact the birth of the baby. | Birth outcomes will be collected using surveys. | Up to 46 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Change, Healthy Pregnancy, Physiologic Sensors
Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.

Official Title
-----------------
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Conditions
-----------------
Allergic Rhinoconjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients aged 18-70 years Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period Exclusion Criteria: pregnancy and nursing women, drug addicts and persons unable to give consent to study participation, patients with intolerance against ingredients of any of the study treatments, previous eye or nose surgery, concomitant treatment with anti-allergic drugs, and diseases which might influence the output of the study according to the physicians' judgment. contra indications according to the label

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 |
| --- | --- |
| Azelastine group<br>Azelastine nasal spray Azelastine eye drops | |
| Ectoin group<br>Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in primary allergic symptoms symptoms | Change in the primary allergic nasal and ophthalmic symptoms: Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness) | Day1, Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatal itching score |  | day 1 and day 7 | 
| Efficacy and tolerability assessment by the patients | Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8 | day1 and day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ectoine, allergic rhinitis, bitop
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

Detailed Description
-----------------
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms: Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Official Title
-----------------
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV-1 seropositive status. CD4 count greater than 100 cells/mm3. Parental consent for patients under 18.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|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
-----------------
HIV-1, Dose-Response Relationship, Drug, HIV Protease Inhibitors, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve PWS therapeutic outcome.

Detailed Description
-----------------
The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.

Official Title
-----------------
Phase I Combined Use of Pulsed Dye Laser and Rapamycin

Conditions
-----------------
Port Wine Stain

Intervention / Treatment
-----------------
* Drug: Rapamycin Treatment of Port Wine Stain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: port wine stain birthmarks suitable for comparison testing. Exclusion Criteria: Pregnancy. Abnormal blood hematology or chemistry blood tests or urine analysis. History of cancer, History of high cholesterol, lipids or liver disease Allergy to macrolide drugs (e.g., erythromycin). Any therapy within the previous two months to the proposed PWS treatment sites. Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of Port Wine Stain<br>Rapamycin Treatment of Port Wine Stain | Drug: Rapamycin Treatment of Port Wine Stain<br>* Treatment of Port Wine Stain<br>* Other names: Treatment of Port Wine Stain;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve port wine stain (PWS) therapeutic outcome |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypervascular anomalies
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.

Official Title
-----------------
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children

Conditions
-----------------
Colloid Osmotic Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn Exclusion Criteria: Syndromes

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Birth asphyxia<br>Babies suffering from birth asphyxia | |
| Blood transfusion<br>Babies who receives blood transfusion | |
| Heart Surgery<br>Babies who need heart surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colloid osmotic pressure |  | 6, 12, 24, 48, 72 hours post partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colloid Osmotic pressure in interstitial fluid, Colloid Osmotic pressure in plasma, Protein fractions in interstitial fluid
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.

Official Title
-----------------
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rectal adenocarcinoma Clinical staged T3/4 or any node-positive disease Age of 18-75 years Karnofsky Performance Status > 80 Adequate bone marrow reserve, renal and hepatic functions Without previous antitumoural chemotherapy No evidence of metastatic disease Written informed consent before randomization UGT1A1's genotype of 6/6 or 6/7 Exclusion Criteria: Clinical staged I or IV Age of <18 or >75 years Karnofsky Performance Status < 80 Previous pelvis radiotherapy Previous antitumoural chemotherapy Clinically significant internal disease Refuse to write informed consent before randomization UGT1A1's genotype of 7/7

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: experimental arm<br>peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation | Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy<br>* dosimetric limitation of pelvic bone and peritoneal space during radiotherapy<br>|
| No Intervention: control arm<br>normal dosimetric limitation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Who Experienced Tumor Down-staging |  | up to 3 years |
ECMO: Optimization of Its Use

Study Overview
=================
Brief Summary
-----------------
To create a local registry for ECMO patients.

Detailed Description
-----------------
To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.

Official Title
-----------------
Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use

Conditions
-----------------
Extracorporeal Membrane Oxygenation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 requiring ECMO. For the control,Patients without ECMO admited to ICU. Exclusion Criteria: Age<18 Known prisoner of the state

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 |
| --- | --- |
| VA ECMO<br>Patients who are placed on VA ECMO. | |
| VV ECMO<br>Patients who are placed on VV ECMO. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 48 hours | 
| In-house mortality |  | 30 day |
Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle

Study Overview
=================
Brief Summary
-----------------
Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7 7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.

Conditions
-----------------
Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.

Intervention / Treatment
-----------------
* Procedure: lumbar sympathetic ganglion block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults above age of 20 Undergoing lumbar sympathetic ganglion block indication Exclusion Criteria: Infection Bleeding tendency Previous spinal surgery history Pregnancy Illiteracy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: block method: angle<br>The entry angle of angular method which is one method of lumbar sympathetic ganglion block is 30 degree of anterior-posterior view of C-arm. | Procedure: lumbar sympathetic ganglion block<br> <br> |
| Active Comparator: block method: distance<br>The entry point of modified Reid method which is popular method of lumbar sympathetic ganglion block is 7 7.5cm from midline of spinous process of lumbar spine. | Procedure: lumbar sympathetic ganglion block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temperature change |  | 30min | 
| muscle or vessel shadow |  | 30min |