linjc16/ctgov huggingface dataset:
Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash

Study Overview
=================
Brief Summary
-----------------
Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.

Official Title
-----------------
100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)

Conditions
-----------------
Skin Irritation

Intervention / Treatment
-----------------
* Other: Cetaphil Restoraderm Skin Restoring Body Wash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently under a doctor's care Free of dermatological or systemic disorder which would interfere with the results Free of any acute or chronic disease Will complete a preliminary medical history form and are in general good health Can read, understand, and sign informed consent Exclusion Criteria: Under 18 years old Currently under doctor's care Currently taking any medication History of acute or chronic disease Diagnosed with chronic skin allergies Pregnant or lactating

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetaphil Restoraderm Skin Restoring Body Wash<br>All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion | Other: Cetaphil Restoraderm Skin Restoring Body Wash<br>* Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of irritation measured to determine sensitivity | 9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks | 3 weeks |
A Longitudinal Observational Study of the Natural History and Management of Patients With HCC

Study Overview
=================
Brief Summary
-----------------
TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Official Title
-----------------
A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, age ≥18 years Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included) Exclusion Criteria: 1. Inability to provide written informed consent

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 |
| --- | --- | --- |
| Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice |  | Up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function |  | Up to 15 years | 
| Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires |  | Up to 15 years | 
| Establish a Biorepository Specimen Bank (BSB) |  | Up to 15 years |
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe acne vulgaris Acne vulgaris unresponsive to oral antibiotics Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study Exclusion Criteria: Use of medications or treatments from specified pre-treatment time periods through the end of the study Beard, moustache, sideburns or other facial hair that may interfere with evaluation Other forms of acne History of malignancy within 5 years History of allergic or anaphylactic reactions to monoclonal antibodies History of tuberculosis History of chronic systemic infections Female subjects who are pregnant, planning to become pregnant Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56<br>|
| Experimental: low dose gevokizumab<br> | Drug: gevokizumab<br>* Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56<br>|
| Experimental: high dose gevokizumab<br> | Drug: gevokizumab<br>* Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean absolute change from baseline in inflammatory facial lesion count at Day 84 |  | Baseline and Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a successful treatment outcome at Day 84 | Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale. | Baseline and Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne, Acne Vulgaris
The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: Hutox Inj
* Biological: Botox Inj


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely Exclusion Criteria: Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day) Any condition that, in the view of the investigator, would interfere with study participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hutox Inj<br>Hutox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) | Biological: Hutox Inj<br>* Hutox Inj(Clostridium botulinum type A)<br>|
| Active Comparator: Botox Inj<br>Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) | Biological: Botox Inj<br>* Botox Inj(Clostridium botulinum type A)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FWS(Facial Wrinkle Severity) Improvement at glabellar line | Change from Baseline of Glabellar Lines improvement rate(Frown) | 4 Weeks |
Magnevist Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A total 2,000 patients will be recruited.

Official Title
-----------------
Drug Use Investigation of Magnevist

Conditions
-----------------
Diagnostic Imaging

Intervention / Treatment
-----------------
* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received a dose of more than 0.2 mg/kg of Magnevist for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist |  | After Magnevist administration, up to 3 years | 
| Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions |  | After Magnevist administration, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extraction |  | After Magnevist injection, up to 3 years | 
| Incidence of adverse drug reactions in subpopulation with baseline data |  | At baseline and after Magnevist administration, up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnevist, MR angiography
FASENRA SCEI for Long-term Use

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

Detailed Description
-----------------
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe. Detection of unexpected Adverse Drug Reactions To grasp development of Adverse Drug Reactions To grasp contributing factors possibly having an impact on the safety and efficacy Development of key investigational safety specification (serious infection).

Official Title
-----------------
FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -The evaluable patients treated with Fasenra for the first time due to Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy). Exclusion Criteria: -No past history of hypersensitivity to the components of Fasenra.
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 |
| --- | --- | --- |
| Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fasenra Benralizumab Bronchial asthma
FIT Combining FC for Predicting MH and Histology Remission in UC

Study Overview
=================
Brief Summary
-----------------
Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.

Official Title
-----------------
FIT Combining FC for Predicting MH and Histology Remission in UC

Conditions
-----------------
Ulcerative Colitis, FIT, Histology Remission, Fecal Calprotetin, Mucosal Healing

Intervention / Treatment
-----------------
* Other: FIT + FC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative colitis patients. Exclusion Criteria: GI bleeding
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FIT combingning FC with colonscopy<br> | Other: FIT + FC<br>* FIT + FC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic value of FIT and/without FC on predicting MH | diagnostic value of FIT and/without FC on predicting MH, Mayo score will be used. | 2 weeks |
Genetic Susceptibility to Factor VIII Inhibitors

Study Overview
=================
Brief Summary
-----------------
This international study will identify genetic factors that may influence the development of inhibitory antibodies in patients with hemophilia A after treatment with factor VIII. Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous research indicates that genetic factors play a role in the development of inhibitors. A better understanding of the influence of genes in this treatment complication may be helpful in predicting, treating or preventing inhibitors. People in families in which one or more members have severe factor VIII deficiency and one or more have a history of an inhibitor may be eligible for this study. Participants fill out a form with questions about the person's relationship to other family members taking part in the study. Those with hemophilia provide a brief medical history, including hemophilia-related information, inhibitor history and the presence of other conditions such as hepatitis C and HIV. All participants have a blood sample taken for laboratory and research tests.

Detailed Description
-----------------
In collaboration with investigators of the Hemophilia Inhibitor Genetic Study (HIGS) multicenter study and the University of Lund, University Hospital, Malmo, Sweden, we propose to assess the role of genetic variants in the process of developing inhibitors to Factor VIII in persons with hemophilia. The discovery of genetic associations offers the potential to direct clinical management in order to prevent inhibitor development and improve clinical care in patients with inhibitors.

Official Title
-----------------
Factor VIII Inhibitor Formation: Identifying Predisposing Genetic Factors

Conditions
-----------------
Hemophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA DNA and relevant clinical data from properly consented hemophiliac subjects and family members (maximum estimated = 3500) will be provided to the LGD for genotyping and analysis. EXCLUSION CRITERIA No available subjects will be excluded to maximize power.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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 |
| --- | --- | --- |
| Collection from 3500 donors |  | Every six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP, Hemophilia, Antibody, Mutations, clotting
Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity. Researchers are interested in determining the effects of Vigabatrin on brain blood flow and glucose use.

Detailed Description
-----------------
This double-blind placebo-controlled parallel design protocol will investigate the effects of gamma-vinyl-GABA (vigabatrin--GVG) an experimental antiepileptic drug, on cerebral glucose metabolism (LCMRglc), blood flow (CBF), and seizure frequency, in patients with uncontrolled complex partial (CPS) and secondary generalized seizures (GTCS). Positron Emission Tomography (PET) will be used to measure CBF and LCMRglc.

Official Title
-----------------
The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism

Conditions
-----------------
Epilepsy, Epilepsy, Complex Partial

Participation Criteria
=================
Eligibility Criteria
-----------------
Localization-related epilepsy. Uncontrolled seizures. Ability to tolerate tegretol monotherapy. No systemic illness requiring drug therapy. No illness that might be made worse by vigabatrin.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Metabolism, Complex Partial Seizures, Epilepsy
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.

Official Title
-----------------
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea

Conditions
-----------------
Gastroesophageal Reflux, Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Continuous positive airway pressure ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes Exclusion Criteria: any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Continuous positive airway pressure ventilation|CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in GERD symptoms | Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls. | 24 hours |