linjc16/ctgov huggingface dataset:
Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Official Title
-----------------
Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age Erectile Dysfunction Exclusion Criteria: History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy Other exclusion criteria apply according to the Summary of Product Characteristics

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10mg taken 1 hours before sexual intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function- Erectile Function domain |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment Questionnaire (GAQ) |  | 8 weeks | 
| Safety and tolerability |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.

Official Title
-----------------
A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Biological: SANGUINATE™
* Drug: Hydroxyurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Homozygous (HbSS) Sickle Cell Anemia; Hb levels: >6g/dL - <10g/dL; Age : >18 years old; Frequency of ER hospitalizations < 6x/yr for SCD pain events documented medical history. Exclusion Criteria: Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks; Allergic to Hydroxyurea; History of clinical significant disease, as determined by the Investigator; History of allergy or major allergic reaction considered to be clinically significant by the Investigator; Screening assessments considered to be abnormal by the Investigator; Patient has sever pulmonary hypertension (index >3 meters per sec); Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period; Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;

Ages Eligible for Study
-----------------
Minimum Age: 19 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: SANGUINATE™<br>PEG-bHb-CO | Biological: SANGUINATE™<br>* 40 mg/mL intravenous infusion.<br>|
| Active Comparator: Hydroxyurea<br>Standard of care for Sickle Cell treatment, 15 mg/kg. | Drug: Hydroxyurea<br>* Standard of care for Sickle Cell treatment, 15 mg/kg.<br>* Other names: Brand Names includes: Hydria, Droxia.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients. | Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SANGUINATE
Use of the SNAP II Electroencephalography (EEG) Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor accurately reflects changes in sedation level in outpatients undergoing surgery or procedures with sedation.

Official Title
-----------------
Use of the SNAP II EEG Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Other: SNAP II EEG System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I, II or III physical status Exclusion Criteria: Use of inhalation general anesthesia ASA IV physical status

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 |
| --- | --- |
| Outpatient Surgery with Sedation<br>SNAP II EEG data will be recorded continuously during the sedation and intermittently compared to routinely monitored parameters of sedation adequacy including vital signs, patient movement, grimacing, verbal complaints, and patient responsiveness to verbal and tactile stimuli. Following surgery, patients will be questioned to determine recall or memory of discomfort. | Other: SNAP II EEG System<br>* A portable EEG monitor (SNAP II EEG System, Everest -St. Louis) is unique in that it monitors both low frequency EEG signals (1-40 Hz), which are typically used, and high frequency EEG signals (80-420 Hz), which are not usually used, and calculates a derived EEG parameter (the SNAP Index). The SNAP Index ranges from 100 (completely awake) to 0 (no brain activity) and has been shown in a few studies to correlate with increasing sedation and loss of consciousness in human volunteers and patients receiving general anesthesia during surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of participant heterogeneity between SNAP Index and OASS Score. | The SNAP Index is a derived EEG (electroencephalogram) parameter (from the SNAP II EEG System) ranging from 100 (completely awake) to 0 (no brain activity). The Observer's Assessment of Alertness/Sedation Score (OASS) is a score derived from motor and sensory functions between 0 and 5 where 0 is unresponsive and 5 is awake. | up to 1 day post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients having outpatient surgery with sedation, patients having procedures with sedation
The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.

Detailed Description
-----------------
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC. METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed. Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.

Official Title
-----------------
The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: interferon-alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with p48 Positive who underwent a curative resection of HCC Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interferon-alpha (IFN-alpha)<br>the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months | Drug: interferon-alpha<br>* interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months<br>* Other names: SINOGEN;|
| No Intervention: control<br>no interventions were assigned | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-years survival rate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, interferon-alpha, p48
Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy (DS01)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.

Official Title
-----------------
Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy

Conditions
-----------------
Brain Cancer, Prostate Cancer, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid tumors in the intracranial, thoracic, or pelvic regions. Exclusion Criteria: N/A -

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 |
| --- | --- | --- |
| Patients with hypoxic tumor identified by tumor blood flow measurement. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proton radiation, tumor blood flow
Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image with ADC value measurement, and to determine the relationship between these data and the degeneration of IVDs, the different posture, and different stress-loading status.

Official Title
-----------------
Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.

Conditions
-----------------
Spinal Cord Injury, Degenerative Spinal Disease.

Intervention / Treatment
-----------------
* Procedure: imaging diagnostics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of spinal cord injury and degenerative spinal disease Normal volunteers Exclusion Criteria: - Patients with cancer and infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: select from the option menu<br>select from the option menu | Procedure: imaging diagnostics<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc Perfusion |  | 3 months |
Diagnostic Usefulness of Fluorine-18-α-Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient

Study Overview
=================
Brief Summary
-----------------
L-[3-18F]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. This study was conducted to investigate a usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in patients with suspected malignancy.

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of BHL in cancer patient. Exclusion Criteria: The patients that PET imaging using 18F-FDG and 18F-FMT was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the PET study, and patient having diabetes mellitus.
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 |
| --- | --- | --- |
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

Study Overview
=================
Brief Summary
-----------------
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

Official Title
-----------------
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 1 or 2 diabetes mellitus. Diagnosis of painful DPN for at least 12 months but less than 5 years in duration. Exclusion Criteria: Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain. Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

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: pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score |  |  |
Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.

Official Title
-----------------
11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls

Conditions
-----------------
Prader-Willi Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prader-Willi syndrome confirmed by molecular testing, ages 6 months to adult Controls: Age-matched, sex-matched, developmentally normal, BMI-controlled healthy or obese subjects Exclusion Criteria: PWS subjects without molecular confirmation of the diagnosis Subjects receiving glucocorticoid treatment within 3 months of evaluation Subjects receiving growth hormone within one year prior to analysis

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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 |
| --- | --- |
| PWS not receiving Growth Hormone<br> | |
| Control subjects healthy or obese<br> | |
| PWS subjects starting Growth Hormone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors

Study Overview
=================
Brief Summary
-----------------
The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.

Detailed Description
-----------------
Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors. Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events. Establish a model to predict aRPs and guide clinical treatment.

Official Title
-----------------
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study

Conditions
-----------------
Cancer Patients

Intervention / Treatment
-----------------
* Radiation: Cancer patients underwent thoracic intensity-modulated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically or cytologically confirmed malignant tumor Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy Exclusion Criteria: Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy Non-thoracic radiotherapy patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Cancer patients underwent thoracic intensity-modulated radiotherapy|Cancer patients underwent thoracic intensity-modulated radiotherapy, previously received ICIs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors. | All suspected diagnoses of pneumonitis (regardless of grade) were centrally reviewed by a multidisciplinary committee consisting of at least one radiologist, pulmonologist, and oncologist. CT (or PET-CT) imaging was reviewed for each patient, which was then compared to the radiation treatment plan; other causes such as infection or tumor progression had to be ruled out using the appropriate workup. | 6 months after last-patient- radiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Immune checkpoint inhibitor, Pneumonitis, Risk factors, IMRT