linjc16/ctgov huggingface dataset:
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Study Overview
=================
Brief Summary
-----------------
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered On Demand to Patients With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: placebo
* Drug: tadalafil
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 months history of erectile dysfunction (ED) Anticipate a monogamous relationship with a female sexual partner Be able to make minimum required sexual intercourse attempts Abstain from using any other ED treatment Exclusion Criteria: Other primary sexual disorders History of radical prostatectomy or other pelvic surgery that affected being able to have an erection History of penile implant or clinically significant penile deformity. Nitrate use Certain heart problems

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablet | Drug: placebo<br>* placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks<br>|
| Active Comparator: 2<br>5 mg tadalafil | Drug: tadalafil<br>* 5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks<br>* Other names: IC351;|
| Active Comparator: 3<br>10 mg tadalafil | Drug: tadalafil<br>* 10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks<br>* Other names: IC351;|
| Active Comparator: 4<br>20 mg tadalafil | Drug: tadalafil<br>* 20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks<br>* Other names: IC351;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint of various questions from the IIEF and SEP diary |  | 12 weeks |
Case Management and Environmental Control in Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Controlled demonstrations of reductions in disproportionate hospital or emergency care are limited. We performed a controlled clinical trial of an Asthma Coach to reduce hospitalizations among low-income, African American children.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Asthma coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-8 years of age Admitted to hospital for acute asthma African American ethnicity Medicaid coverage Exclusion Criteria: Parent refusal to sign consent Living outside service area

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care consisted of referral back to primary care provider after index hospitalization | |
| Experimental: Behavioral<br>Asthma coaching, inperson contact followed by telephone contact | Behavioral: Asthma coaching<br>* Inperson contact followed by telephone with approach by issues raised by family<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department visits |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, children, low-income, underserved, Reduction in hospitalization
Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

Study Overview
=================
Brief Summary
-----------------
This study is designed as an observational study to collect Cardiospire cardiogenic oscillation signal (COS) and CO output parameters from the Pulmonary Artery Catheter in intubated patients.

Detailed Description
-----------------
Respirix has developed a non-invasive hemodynamic monitoring device called the Cardiospire. The Cardiospire detects minor, cyclic waveforms caused by Cardiogenic Oscillations (COS) and uses features of the COS waveform to provide information about hemodynamics. This study is designed as an observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients.

Official Title
-----------------
Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Device: Cardiospire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Intubated Pulmonary artery catheter Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: Subjects who, at the principal investigator's determination, would not be appropriate for this study

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

| Intervention/Treatment |
| --- |
|Device: Cardiospire|Non-invasive hemodynamic monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatable Data Verification | First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS). | 3 months | 
| Correlation and Validation of data | Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes. | 1.5 years |
Quantification of Transition Metals

Study Overview
=================
Brief Summary
-----------------
In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating physicians as well as the patients will not be informed about the results of drug concentrations.

Detailed Description
-----------------
Samples used include: Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol. The objective of this study is to gain an overview about transition metals concentrations in blood serum and CSF in order to provide preliminary data on patients. The effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.

Official Title
-----------------
Quantification of Transition Metals in Patients at the Cologne University Hospital

Conditions
-----------------
Neurodegenerative Diseases, Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • The trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture. Exclusion Criteria: • The lower age limit is 18 years. In concordance with the objective of the project there is no specific exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with Parkinson´s Disease<br> | |
| Patient´s with Alzheimer´s Disease<br> | |
| Patients with Multiple Sclerosis<br> | |
| Patients with any other neurodegenerative diseases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition metal concentration |  | 5 years |
Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong

Study Overview
=================
Brief Summary
-----------------
Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis. There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to answer the following questions: the paternal, maternal and obstetric factors leading to immunoprophylaxis failure the prevalence of immunoprophylaxis failure in Hong Kong

Conditions
-----------------
Hepatitis B Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women age ≥ 18 years Maternal or paternal hepatitis B carrier Exclusion Criteria: Couples will be excluded if female partners of paternal hepatitis B carrier were occult carrier Plan to deliver in other units

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 |
| --- | --- |
| Maternal hepatitis B carrier<br> | |
| Paternal hepatitis B carrier<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off |  | Infants' blood for HbsAg at 9-12 months old |
Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.

Official Title
-----------------
Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.

Conditions
-----------------
Kidney Diseases, Kidney Transplant; Complications, COVID-19, Vaccine Adverse Reaction, Rejection Acute Renal, Rejection Chronic Renal

Intervention / Treatment
-----------------
* Biological: Booster dose of mRNA vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM) vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273) immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil COVID naive Exclusion Criteria: age < 18 years pregnant women, breastfeeding women unable/unwilling to give informed consent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First booster dose group<br> | Biological: Booster dose of mRNA vaccine<br>* Administration of SARS-CoV-2 mRNA vaccine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological safety - anti-HLA antibodies | Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level. | Comparison of anti-HLA single antigen bead assays at booster dose and three months later. | 
| Immunological safety - donor-derived cell-free DNA | Elevation of dd-cfDNA above 1% threshold | Comparison of dd-cfDNA assays at booster dose and three months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological effectiveness - anti-SARS-CoV-2 antibodies | Emergence or increase of anti-SARS-CoV-2 IgG. | Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplantation, COVID-19, mRNA vaccine, vaccine safety, alloreactivity
An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia

Study Overview
=================
Brief Summary
-----------------
This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.

Official Title
-----------------
Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: epoetin beta [NeoRecormon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >/=18 years of age Dialysis patients with chronic renal anemia Written informed consent Exclusion Criteria: Red blood cell transfusion in the previous 2 months Severe neuropsychological disorder Diabetic patients with serious complications This trial is being conducted in Morocco.

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

| Intervention/Treatment |
| --- |
|Drug: epoetin beta [NeoRecormon]|As prescribed by physician|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment: Kidney Disease Quality of Life Questionnaire |  | Throughout study: 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life |  | Throughout study: 6 months |
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

Official Title
-----------------
Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors

Conditions
-----------------
Skin Cancer, Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: rapamycin
* Drug: ciclosporine
* Drug: tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors Exclusion Criteria: Other squamous cell carcinomas in the past history More than 2 transplantations Patients not under calcineurin inhibitors Unstable graft function Non controlled hyperlipidemia (cholesterol > 7.8 mmol/l or triglycerides > 3.95 mmol/l) Leucopenia < 3000/mm3 Thrombocytopenia < 100,000/mm3 Liver dysfunction Pregnancy Allergy to macrolides

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>patients receiving Rapamycin | Drug: rapamycin<br>* 3 to 5 mg/day<br>* Other names: Rapamune;|
| Active Comparator: 2<br>patients receiving anticalcineurin treatment | Drug: ciclosporine<br>* Blood residual level < or = to 125 ng/ml<br>Drug: tacrolimus<br>* Blood residual level < or = to 8 ng/ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the incidence of new squamous cell carcinoma in kidney transplant recipients |  | during 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the incidence of other non skin cancer in kidney transplant recipients |  | during 5 years | 
| To assess the graft survival |  | during 5 years | 
| To assess the tolerance of rapamycin |  | during 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients
Dementia Management With Interactive Technology

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.

Official Title
-----------------
Dementia Management With Interactive Technology

Conditions
-----------------
Dementia, Memory Disorders in Old Age

Intervention / Treatment
-----------------
* Behavioral: Individualized Care Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents living in a specific locked memory care unit in Southeastern Louisiana or Family or staff identified as part of the care team of the resident

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Memory Care Unit Residents<br>Residents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident. | Behavioral: Individualized Care Plan<br>* Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality/Survival Rate |  | through study completion, an average of 1 year | 
| Quality of Life Scale (QoL) | Neuropsychiatric/behavioral symptoms | through study completion, an average of 1 year | 
| Fall Incidence | Neuropsychiatric/behavioral symptoms | through study completion, an average of 1 year | 
| Zarit Caregiver Burden | Family burden | through study completion, an average of 1 year | 
| Patient Care Team Burden Scale (PCTB) | staff caregiver burden | through study completion, an average of 1 year | 
| Healthcare Utilization | Number of visits to hospital or clinic | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit Charge HR activity and sleep data | Average daily steps, minutes asleep | through study completion, an average of 1 year |