linjc16/ctgov huggingface dataset:
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Conditions
-----------------
Hypoactive Sexual Desire Disorder

Intervention / Treatment
-----------------
* Drug: testosterone gel
* Drug: placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between the ages of 30 to 65 years Must have undergone hysterectomy and bilateral salpingo-oophorectomy Exclusion Criteria: A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation Any systemic skin diseases or local skin abnormalities in the area of application Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder). A medical condition that could affect or interfere with sexual function Using a systemic topical gel or cream estrogen therapy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone gel<br>1% testosterone transdermal gel | Drug: testosterone gel<br>* once daily transdermal testosterone gel, 300 mcg<br>* Other names: LibiGel;|
| Placebo Comparator: placebo gel<br>placebo transdermal gel | Drug: placebo gel<br>* once daily transdermal placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score. |  | Baseline and 21-24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline over time for multiple efficacy measurements |  | change over timepoints from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoactive sexual desire disorder, testosterone, menopause
Platelets in Acute Wounds: A Pilot Study (PAWS)

Study Overview
=================
Brief Summary
-----------------
Comparison of wound healing treatments; platelet gel vs. control

Detailed Description
-----------------
Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome.

Official Title
-----------------
Platelets in Acute Wounds: A Pilot Study (PAWS)

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Procedure: application of autologous platelet gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smokers, >18 years of age, BMI<30 - Exclusion Criteria: Smokers, obese, keloid formers, bleeding disorders, medications -

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: application of autologous platelet gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete closure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 
| long-term scar appearance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute wounds, wounds, platelets, platelet gel
Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures

Study Overview
=================
Brief Summary
-----------------
Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures

Detailed Description
-----------------
Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.

Official Title
-----------------
Small Catheter Drainage With Chest Tube After Uniport Video-assisted Thoracoscopic Procedures

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Device: central venous catheter (small catheter drainage)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative Exclusion Criteria: Patients who do not need intercostal tube post operative
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
Interventional Model Description: case of small catheter drainage with chest tube versus chest tube alone after uniport vats
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small catheter with chest tube after uniport vats<br>Insertion of small catheter drainage in the same opening with chest tube after uniport vats | Device: central venous catheter (small catheter drainage)<br>* Insertion central venous catheter ( small catheter drainage ) after uniport vats to decrease hospital stay and to easy drainage after procedure<br>|
| No Intervention: Chest tube only after uniport vats<br>After uniport vats we put chest tube only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with failure of initial intervention | Number of participants with failure of initial intervention , Requiring a second intervention i.e.insert second tube | one year |
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

Study Overview
=================
Brief Summary
-----------------
NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it. Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.

Official Title
-----------------
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy

Conditions
-----------------
Triamcinolone Acetonide, Optic Neuropathy, Ischemic

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days) Exclusion Criteria: Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcinolone Acetonide<br>40mg/1ml | Drug: Triamcinolone Acetonide<br> <br> |
| Placebo Comparator: placebo<br>1ml | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Best corrected visual acuity(BCVA) |  | baseline and 1month, 3month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Visual Field |  | baseline and 1month, 3month |
Differential Metabolic Effects of Fenofibrate and Fatty Acid

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: fenofibrate, fatty acid, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertriglyceridemia Exclusion Criteria: Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fenofibrate<br> | Drug: fenofibrate, fatty acid, placebo<br>* fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment<br>|
| Active Comparator: fatty acid<br>drug | Drug: fenofibrate, fatty acid, placebo<br>* fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment<br>|
| Active Comparator: Placebo<br> | Drug: fenofibrate, fatty acid, placebo<br>* fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance
Role of Anti-IgE in Severe Childhood Eczema

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.

Detailed Description
-----------------
To address the value of anti-IgE in children with severe eczema.

Official Title
-----------------
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema

Conditions
-----------------
Atopic Eczema, Atopic Dermatitis, Child

Intervention / Treatment
-----------------
* Drug: Xolair
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of 4-19 years Severe eczema Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR Clinical impression that allergic exposures cause worsening eczema. Total IgE level >300 kU/l Clinically proven IgE-mediated allergic disease. Written informed consent to participate. Exclusion criteria: Inability to comply with 2-4 weekly injections and clinic visits Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions. Uncontrolled infection or unstable eczema. Malignancy or a history of malignancy. Pre-existing hepatic or renal impairment Known cardiovascular or ischaemic cerebrovascular abnormality. Other serious or uncontrolled systemic disease. Pregnancy or lactation. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents. Insufficient understanding of the trial assessments. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater. Investigator feels that there is a good clinical reason why the child would be unsuitable.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xolair/Omalizumab<br> | Drug: Xolair<br>* According to manufacturer's instructions<br>* Other names: Omalizumab;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in atopic eczema |  | 24 weeks after treatment commences |
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.

Official Title
-----------------
A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

Conditions
-----------------
Sarcoma, Neutropenia

Intervention / Treatment
-----------------
* Drug: pegfilgrastim
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Ages Eligible for Study
-----------------
Maximum Age: 21 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: Filgrastim<br>Filgrastim | Drug: filgrastim<br>* filgrastim<br>|
| Experimental: Pegfilgrastim<br>Pegfilgrastim | Drug: pegfilgrastim<br>* pegfilgrastim<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe neutropenia in chemotherapy in cycles 1 and 3 |  | cycles 1 and 3 | 
| Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 |  | cycles 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile in chemotherapy cycles 1 and 3 |  | cycles 1 and 3 | 
| Incidence of adverse events across all cycles of chemotherapy |  | all cycles | 
| Overall rates of febrile neutropenia |  | all cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone cancer, Sarcoma, Neutropenia, Chemotherapy
Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

Study Overview
=================
Brief Summary
-----------------
This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.

Detailed Description
-----------------
This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.

Official Title
-----------------
Evaluation of a Chest X-Ray AI Neural Network (RadGen SARS-CoV2 Detection System) for the Detection of RT-PCR Confirmed SARS-Cov2 Covid-19 Pneumonia

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: AI model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients >18 years of age Attended any of the participating institutes between February 1, 2020 until September, 2020 Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection frontal CXR of patients pre-covid pandemic Exclusion Criteria: Unavailability of patient demographics and clinical data Inconclusive RT-PCR results CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site CXR not in a retrievable or processable format for AI inference

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| RT-PCR Positive Patients<br>RT-PCR confirmed patients positive for SARS-CoV-2 | Diagnostic Test: AI model<br>* Deep Learning CNN model<br>|
| Negative patients<br>RT-PCR confirmed patients negative for SARS-CoV-2 or patients with CXR performed before the emergence of COVID-19 pandemic | Diagnostic Test: AI model<br>* Deep Learning CNN model<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of AI model | Performance (accuracy, sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), and Area Under the Curve (AUC)) of the AI model in detection of COVID-19 pneumonia on their baseline CXR using RT-PCR and historical controls as gold standard in a multi-center / multi-national cohort. | 9 months |
IN-TANDEM Familial Hypercholesterolemia Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national initiative that utilizes machine learning and data mining techniques to identify individuals whose profiles are consistent with FH patients. The algorithm will be tested in adults with at least one cardiovascular comorbidity. Study subjects will be asked to provide either a saliva, buccal or venous blood sample for DNA and biomarker analysis

Official Title
-----------------
INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Other: Genetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older At least one cardiovascular co-morbidity or receiving treatment for a cardiovascular comorbidity Algorithm score 0-1 Most recent encounter with a provider within five years of query date Exclusion Criteria: Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound study data

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 |
| --- | --- |
| Strata 0-0.05<br>Lowest probability of having familial hypercholesterolemia | Other: Genetic testing<br>* Targeted next-generation sequencing for familial hypercholesterolemia causative mutations<br>|
| Strata 0.06-0.15<br>Second lowest probability of having familial hypercholesterolemia | Other: Genetic testing<br>* Targeted next-generation sequencing for familial hypercholesterolemia causative mutations<br>|
| Strata 0.16-0.19<br>Moderate probability of having familial hypercholesterolemia | Other: Genetic testing<br>* Targeted next-generation sequencing for familial hypercholesterolemia causative mutations<br>|
| Strata 0.20-0.34<br>Second highest probability of having familial hypercholesterolemia | Other: Genetic testing<br>* Targeted next-generation sequencing for familial hypercholesterolemia causative mutations<br>|
| Strata greater than or equal to 35<br>Highest probability of having familial hypercholesterolemia | Other: Genetic testing<br>* Targeted next-generation sequencing for familial hypercholesterolemia causative mutations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likelihood of having FH-causing mutation | Proportion of subjects with causative mutation in higher algorithm score groups | 12 months |