linjc16/ctgov huggingface dataset:
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.

Official Title
-----------------
A Two-part, Open-label, Cross-over Study to Assess the Pharmacokinetics of GSK221149 Following Single Oral Doses of Various Modified Release Formulations and a Solution in Healthy Adult Subjects

Conditions
-----------------
Obstetric Labour, Premature, Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: GSK221149


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and non-pregnant female Between the ages of 18 and 50 years old. Females may be of child-bearing or non-child-bearing potential. Non-smokers BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs). Exclusion Criteria: History of smoking within past 6 months Regular alcohol consumption averaging 7 drinks or more per week Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV Use of prescription or non-prescription drugs within 14 days of study start

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK221149|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session. |  | over a 24 hour period during each study session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session.. |  | over a 24 hour period during each study session. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-term labor,, modified release formulation, pharmacokinetics,
Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Study Overview
=================
Brief Summary
-----------------
Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Detailed Description
-----------------
A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Official Title
-----------------
Open Multicenter Diagnostic Study on the Accuracy of Biomarker Testing (Galactomannan (GM), (1-3)-β-D-glucan (BDG), Aspergillus-specific Polymerase Chain Reaction (PCR) Assay) in Pleural Effusion Samples of Immunocompromised Patients With Suspected Invasive Pulmonary Aspergillosis (IPA)

Conditions
-----------------
Invasive Aspergillosis, Pleural Effusion, Immunosuppression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prolonged neutropenia > 10 d, patients after allogeneic stem cell transplantation or solid organ transplantation, Patients wth acute leukemia in induction treatment, patients witrh graft-versus-host-disease, patients under chronic immunusuppressive therapy such as ciclosporin, patients with HIV, patients with chronic steroid treatment Exclusion Criteria: Age < 18 years missing informed consent contraindication for pleural centesis

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 |
| --- | --- |
| Immunocompromised Patients<br>Immunocompromised patients with suspected IPA who have Pleural effusions act as the observed study population | |
| Control Group<br>Patients without Immunosuppression with pleural effusions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Sensitivity |  | one year |
Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.

Official Title
-----------------
Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study. Active patients of MSK and participating institutions Exclusion Criteria: Patients who have been diagnosed with a tumor greater than 2 cm Patients with clinically suspicious lymphadenopathy in the neck Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor

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 |
| --- | --- |
| Thyroid cancer<br>This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes. | Behavioral: Questionnaires<br>* Quality of Life Questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influencing decision making pre-visit | Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence. | 3 years | 
| influencing decision making post-visit | Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Decision Making, 17-382
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device

Official Title
-----------------
JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic

Conditions
-----------------
Cardiogenic Shock

Intervention / Treatment
-----------------
* Device: Impella CP microaxial pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiogenic shock following acute MI or acute heart failure with systolic BP < 90 mm Hg over > 30 min or inotropes for support of cardiac output and BP with signs of left heart failure and pulmonary congestion and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate >2 mmol/l Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 91 Years

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

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

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 |
| --- | --- |
| Experimental: Intervention<br>Impella implantation and hemodynamic measurement | Device: Impella CP microaxial pump<br>* ramp test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Parameters due to PA catheterisation | Pulmonary capillary Wedge pressure in dependence of Impella pump level | Day 1 | 
| Echocardiographic Parameters of left and right heart function | LV- size in dependence of Impella pump level | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impella
Corneal Oxygen Uptake With Apioc Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.

Official Title
-----------------
Corneal Oxygen Uptake With Apioc Contact Lenses

Conditions
-----------------
Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)

Intervention / Treatment
-----------------
* Device: Apioc Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide informed consent. Appear willing and able to adhere to instructions set forth in the protocol. Be between the ages of 18 and 45. Be an experienced contact lens wearer. Be an eyecare clinician or clinician-in-training. Flat and steep keratometry readings within 40 to 50D. Clear, healthy corneas with no irregular astigmatism. Normal, healthy conjunctiva in both eyes. Be able to provide corneal topography measurements. Be able to provide manifest refraction measurements. Exclusion Criteria: Irregular corneal astigmatism. Use of topical or systemic antihistamines within the previous week. Use of topical ophthalmic drops within the previous two days. History of corneal surgery. Currently pregnant or lactating. Systemic disease that would interfere with contact lens wear. Previous diagnosis of dry eye syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Apioc Contact Lens|Measurement of corneal oxygen uptake with contact lens wear.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Oxygen Uptake Rate | uptake of oxygen by human cornea in vivo | up to 45 seconds |
A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.

Official Title
-----------------
A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients

Conditions
-----------------
Venous Thromboembolism, Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all the patients in ICUs estimated time in ICU mare than 48h Exclusion Criteria: estimated time in ICU less than 48h refused to attend

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 |
| --- | --- | --- |
| the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients | at the same time, to analyze the risk factor of the occurrence of venous thromboembolism despite of thromboprophylaxis | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of bleeding events under thromboprophylaxis in critical ill patients | at the same time, to analyze the risk factors of bleeding in critical ill patients who receive thromboprophylaxis | 2 weeks |
Fundus Autofluorescence Imaging in Age-related Macular Degeneration Using Confocal Scanning Laser Ophthalmoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define phenotypic variations in atrophic Age-Related Macular Degeneration (AMD) and to identify predictive factors for disease progression based on fundus autofluorescence imaging.

Detailed Description
-----------------
Age-related macular degeneration (AMD) is the leading cause of legal blindness in the industrialized world beyond 50 years of age. Ageing changes of the retinal pigment epithelium (RPE) play a key role in the pathogenesis of the disease. In postmitotic RPE cells autofluorescent lipofuscin granules accumulate with age in the lysosomal compartment mainly as a byproduct of constant phagocytosis of membranous disks shed from photoreceptor outer segments. With the advent of confocal scanning laser ophthalmoscopy fundus autofluorescence mediated by RPE-lipofuscin accumulation can be visualized in vivo: We plan to identify fundus autofluorescence changes as predictive factors for the development of late stage manifestations and their variation over time. Furthermore, we plan to determine the effect of increased focal accumulations of autofluorescent material on retinal sensitivity using fundus perimetry. Examination of human donor eyes with AMD will allow for correlation of fundus autofluorescence alterations in vivo and in vitro. These investigations will be performed not only to better understand the role of lipofuscin accumulation in AMD but also to manipulate these mechanisms for both experimental and therapeutic ends.

Official Title
-----------------
Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy

Conditions
-----------------
Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be considered reliable, willing and able to give informed consent. Age >50 years (male or female) Must have age-related macular degeneration in at least one eye Clear media to allow imaging Exclusion Criteria: any history of retinal surgery, including laser treatment, photodynamic therapy, radiation or intravitreal injections history of retinal vascular occlusions any concurrent intraocular condition that, in the opinion of the investigator, could exclude the patient from the medical or ethical point of view

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

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

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 |
| --- | --- | --- |
| Change of geographic atrophy size to baseline |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-related macular degeneration, Geographic atrophy, drusen
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

Conditions
-----------------
Skin Aging

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe crow's feet lines Female or male, 18 to 65 years of age and in good general health Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study Exclusion Criteria: Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A Muscle weakness or paralysis, particularly in the area receiving study treatment Active skin disease or irritation at the treatment area Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart Treatment with botulinum toxin type A for crow's feet lines in the last 6 months

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose A<br>Dose A: Botulinum toxin type A | Drug: Botulinum Toxin Type A<br>* Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines<br>|
| Placebo Comparator: Dose B<br>Dose B: Placebo | Drug: Placebo<br>* Placebo, Dose B; dose applied to the lateral canthal lines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment |  | Week 4 | 
| Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment |  | Week 4 | 
| Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment |  | Week 4 |
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

Study Overview
=================
Brief Summary
-----------------
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Official Title
-----------------
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: dabigatran etexilate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: males or females 1 to less than 2 years of age objective diagnosis of primary venous thromboembolism completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism written informed consent by parent (legal guardian) and patient assent (if applicable) Exclusion criteria: weight less than 9 kg conditions associated with increased risk of bleeding patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 2 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: dabigatran etexilate<br>single dose treatment with dabigatran oral solution | Drug: dabigatran etexilate<br>* age & weight adjusted equivalent of adult dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ecarin clotting time (ECT) |  | one day | 
| Factor IIa inhibition |  | one day | 
| Incidence of all bleeding events |  | 30 days | 
| Incidence of all adverse events |  | 30 days | 
| Plasma concentrations of total dabigatran |  | one day | 
| Plasma concentrations of free dabigatran |  | one day | 
| Plasma concentrations of BIBR 1048 BS (Base) |  | one day | 
| Plasma concentrations of BIBR 951 BS |  | one day | 
| Plasma concentrations of BIBR 1087 SE (Acid) |  | one day | 
| Activated prothrombin time (aPTT) |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of tolerability will be summarized across all patients in the treated set |  | 30 days | 
| Patient assessment of taste will be summarized across all patients in the treated set |  | one day | 
| Changes in laboratory and clinical parameters |  | 30 days |