linjc16/ctgov huggingface dataset:
Work of Breathing and Kangaroo Mother Care

Study Overview
=================
Brief Summary
-----------------
To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.

Official Title
-----------------
The Impact of Kangaroo Mother Care on Work of Breathing Indices and Oxygen Saturation Stability in Very Low Birth Weight Infants

Conditions
-----------------
Premature Infant, Work of Breathing, Oxygen Saturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infants (those less than 1500g at birth) Respiratory insufficiency >4d PMA Stable and receiving non-invasive respiratory support for ≥12 hours (NC, HFNC or CPAP) Requiring ≤40% supplemental FiO2 Exclusion Criteria: Infants with skeletal, neuromuscular or abdominal surgical disorders that may affect the accuracy of work of breathing measurements Infants who do not meet criteria to participate in kangaroo mother care

Ages Eligible for Study
-----------------
Minimum Age: 4 Days
Maximum Age: 6 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all infants<br>There will be one arm for this study. All infants will receive a similar intervention during their routine kangaroo mother care (KMC). KMC is a national and international standard of care. This is an observational study of how infants breath while participating in KMC compared to how they breath while in a crib or incubator. Work of breathing will be measured at baseline and then during KMC. Mothers will participate in KMC regardless of participation in the study. Work of breathing will be measured by using Respiratory Inductance Plethysmography (RIP). This scientifically measures work of breathing (specifically phase angles) by placing soft bands around the abdomen and chest. The actual intervention is a standard of care and something that the mother infant dyad will do regardless of the study. Each mother / infants pair is expected to be actively enrolled for approximately 2 hours. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in work of breathing | Work of breathing will be measured before, during, and after KMC. Comparisons will be made. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | Oxygen saturations will be measured before, during, and after KMC. Comparisons will be made. | 2 hours |
Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)

Study Overview
=================
Brief Summary
-----------------
For patients with atrial fibrillation and heart failure, current treatment can include AV nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure for this patient population which attempts to restore sinus rhythm. This trial is a randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial fibrillation patients with congestive heart failure.

Official Title
-----------------
Randomized Controlled Trial of Pulmonary Vein Antrum Isolation vs. AV Node Ablation With Bi-Ventricular Pacing for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure (PABA CHF)

Conditions
-----------------
Atrial Fibrillation, Congestive Heart Failure

Intervention / Treatment
-----------------
* Procedure: Pulmonary vein isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic atrial fibrillation with NYHA II-III symptoms despite the use of anti-arrhythmic medications. Ejection fraction was required to be ≤ 40%. Patients were required to be on a heart failure regimen that included beta-blockers and ace-inhibitors or angiotensin receptor blockers for all patients and spironolactone for NYHA III patients. Patients were required to complete a 6-minute walk test and to be ≥ 18 years of age. Exclusion Criteria: Reversible causes of AF and heart failure (HF) such as pericarditis, hyperthyroidism, valvular heart disease and tachycardia-induced cardiomyopathy. Post-operative AF, previous MAZE or MAZE-like surgery, previous left atrial instrumentation Life expectancy ≤ 2 years Likely cardiac transplant within the next 12 months Contraindication to anti-arrhythmic medications and/or anticoagulation Severe pulmonary disease Documented intra-atrial thrombus Tumor or other abnormalities which preclude catheter introduction Cardiac surgery, MI or PCI within the past three months.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulmonary vein isolation|Pulmonary vein isolation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of EF, 6-minute walk distance and MLWHF score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from AF and left atrial size |  | 6 months |
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.

Official Title
-----------------
Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers

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

Intervention / Treatment
-----------------
* Drug: dorzolamide hydrochloride (+) timolol maleate
* Drug: Comparator: timolol maleate
* Drug: Comparator: dorzolamide hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with glaucoma and ocular hypertension Exclusion Criteria: History of ocular surgery within 3 months Administration contradiction to timolol and dorzolamide

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 |
| --- | --- |
| Experimental: 1<br>combination of dorzolamide hydrochloride and timolol maleate | Drug: dorzolamide hydrochloride (+) timolol maleate<br>* Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week<br>|
| Active Comparator: 2<br>Concomitant use of dorzolamide hydrochloride and timolol maleate | Drug: Comparator: timolol maleate<br>* timolol maleate 0.5%, 8-week<br>Drug: Comparator: dorzolamide hydrochloride<br>* dorzolamide hydrochloride 1%, 8-week<br>|
| Active Comparator: 3<br>timolol maleate | Drug: Comparator: timolol maleate<br>* timolol maleate 0.5%, 8-week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2) | 8 Weeks | 
| Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2) | 8 weeks |
The Effect of Anti-CεmX on IgE Production

Study Overview
=================
Brief Summary
-----------------
Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be effective for patients with much higher serum IgE levels, such as those with atopic dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic patients.

Detailed Description
-----------------
This study will collect blood from patients of high serum IgE levels to investigate the function of h4b12, a humanized mAb specific for mIgE+ B cells, and compare the effects of h4B12, Omalizumab, and Rituxumab on the suppression of IgE production and the number of IgE-producing plasma cells. These blood specimens will be collected from 50 patients of atopic dermatitis or urticaria with high serum IgE levels. Fountain Biopharma will carry out the following two in vitro assays to measure the efficacy of h4B12: IgE ELISA to determine the concentration of IgE. IgE ELISPOTto determine the number of IgE-producing plasma cells.

Official Title
-----------------
The Effect of Humanized Anti-CεmX Antibody (h4B12) on IgE Production in the PBMC Isolated From Atopic Dermatitis Patients

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged ≥ 18 years Clinical diagnosis of atopic dermatitis or chronic urticaria Exclusion Criteria: -

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 |
| --- | --- | --- |
| IgE | mesure IgE production in PBMC culture supernatant | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgE, Atopic Dermatitis, antibody, allergy
Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Official Title
-----------------
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Conditions
-----------------
Gynecological Malignancies, Genital Neoplasms, Female, Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa
* Drug: recombinant human erythropoietin (rHuEPO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for gynecological cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Known positive test for human immunodeficiency virus (HIV) infection

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: darbepoetin alfa|nan|
|Drug: recombinant human erythropoietin (rHuEPO)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia correction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference |  |  | 
| Activities of daily living |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine cancer, ovarian cancer, darbepoetin alfa, Amgen, Gynecological Malignancies
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Study Overview
=================
Brief Summary
-----------------
Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. To address this research gap, the investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.

Official Title
-----------------
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Conditions
-----------------
Pregnancy Anemia, Newborn; Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant volunteers Exclusion Criteria: Hemoglobinopathies Pre-existing diabetes Malabsorption diseases Pregnancy induced hypertension Elevated diastolic blood pressure (>110) Previous treatment for lead exposure or elevated childhood lead concentrations. Preexisting medical conditions known to impact iron homeostasis

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 45 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 |
| --- | --- |
| Pregnant Adolescents<br> | |
| Pregnant Women Carrying Multiple Fetuses<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Erythroferrone During Pregnancy |  | Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy | 
| Maternal Erythroferrone at Delivery |  | Measures will be obtained from maternal blood collected at delivery | 
| Neonatal Erythroferrone at Birth |  | Measures will be obtained from umbilical cord blood collected at delivery | 
| Placental Erythroferrone mRNA and Ferroportin protein Expression |  | Measures will be obtained from placental samples collected at delivery |
Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon

Study Overview
=================
Brief Summary
-----------------
Juvenile secondary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud's Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud's are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynaud's episodes in juvenile patients.

Conditions
-----------------
Raynaud's Disease

Intervention / Treatment
-----------------
* Drug: Pletal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 5 to 16 years old fulfill diagnostic criteria for primary or secondary Raynaud's

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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: Pletal|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
-----------------
Secondary Raynaud's, circulatory, vascular, scleroderma, lupus, mixed connective tissue disease
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Triamcinolone acetonide
* Drug: Triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory diffuse DME unresponsive to focal laser photocoagulation Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm Exclusion Criteria: Previous ocular surgery Glycosylated hemoglobin (Hb A1C) rate above 10% History of glaucoma or ocular hypertension Loss of vision as a result of other causes Systemic corticoid therapy Severe systemic disease Any condition affecting follow-up or documentation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal (IVI)<br> | Drug: Triamcinolone acetonide<br>* 4 mg<br>|
| Experimental: SubTenon´s (STI)<br> | Drug: Triamcinolone acetonide<br>* 40 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central subfield macular thickness |  | baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  | baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively | 
| Intraocular pressure |  | baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema